Dimension Vista® Cuvettes
Cuvettes, 20x240 (4800)
16manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Beijing Hotgen Biotech Co., Ltd. | Beijing | Beijing | Manufacturer | 13 |
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai | Shandong | Contract manufacturer | 8 |
| Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shanghai Kehua Laboratory System Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JJE |
| Device type | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2160 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K051087 |
| Record published | 2020-09-24 |
| Record revised | 2021-11-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10445211 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alinity | Abbott Medical | 283 |
| Architect | Abbott Laboratories | 115 |
| Alinity | Abbott Laboratories | 18 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 15 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 14 |
| Architect | Abbott Ireland Diagnostics | 8 |
| AU | Beckman Coulter, Inc. | 7 |
| Alinity | Abbott Ireland Diagnostics | 6 |
| DxC AU | Beckman Coulter, Inc. | 6 |
| Chemiluminescence Immunoassay Analyzer | Shenzhen Yhlo Biotech Co., Ltd. | 6 |
| Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300 | Tosoh Corp. | 5 |
| Pictus 500 Clinical chemistry analyzer | Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag | 4 |
Showing 12 of 336. All products under Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130276 | 2013-03-22 |
| K112999 | 2011-11-22 |
Recalls Naming This Product
28 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2021-10-15 | Class II | Software design | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays | 1407 units | 2024-05-13 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2021-10-15 | Class II | Software design | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays | 1326 units | 2024-05-13 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2018-12-12 | Class II | Under Investigation by firm | When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination. | 5373 | 2020-04-27 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2018-10-16 | Class II | Under Investigation by firm | Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the instrument is aliquotting the sample, the | 1649 | 2020-06-17 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2017-03-03 | Class II | Under Investigation by firm | Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15 perce | 2733 systems | 2018-07-03 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2016-03-24 | Class II | Software design | Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse bet | 1301 units | 2017-03-13 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2016-03-24 | Class II | Software design | Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse bet | 1300 | 2017-03-13 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2015-05-21 | Class II | Software design (manufacturing process) | Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in Vista 1500 may cause wrong reagent or no reagent delivery. This may lead to unflagged, une | 2315 | 2017-03-10 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2014-11-05 | Class II | Device Design | Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on th | 1,949 | 2017-10-06 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2014-04-14 | Class II | Nonconforming Material/Component | A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard. | 4 | 2014-12-15 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2013-10-07 | Class II | Software design | When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Car | 2038 | 2014-08-27 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2013-06-19 | Class II | Software Design Change | Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be di | 1937 | 2014-08-27 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2013-05-20 | Class II | Software design | There is the potential for the vial volume of “in use” Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 – Reloaded Vista Vials | 776 | 2014-04-10 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2012-01-16 | Not classified | Software change control | Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the Instructions For Use for | 1,683 | 2014-03-05 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2011-10-31 | Not classified | Material/Component Contamination | Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IM | 6,000 | 2013-12-24 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2011-10-31 | Not classified | Material/Component Contamination | Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IM | 8,242 | 2013-12-24 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2011-10-31 | Not classified | Material/Component Contamination | Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IM | 5,282 | 2013-12-24 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2011-08-08 | Not classified | Nonconforming Material/Component | Siemens Healthcare Diagnostics has confirmed a low frequency defect in the molding of the Cuvettes that may result in Cuvette Ring and Cuvette Loader jams. It has been determined that the issue is related to a molding defect with the Cuvet | 1,786 | 2013-12-24 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2010-07-23 | Not classified | Other | the EasyLink QCFIRST custom rule does not operate as intended. | 82 | 2013-03-19 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2010-05-05 | Not classified | Nonconforming Material/Component | Defective batteries used in the Alpha Pinnacle P10 UPS External Battery Pack may overheat and cause a strong sulfuric odor to be released and a corrosive sulfuric acid solution leak to occur. | 228 units | 2010-10-25 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2010-03-15 | Not classified | Process design | Vessel pick up errors and vessel jams when the vessel is being loaded. The error halts the instrument and disrupts processing. Vessel flange is thin. | 5544 bags | 2010-08-03 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2009-11-24 | Not classified | Nonconforming Material/Component | Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable. | 408 units | 2011-09-08 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2009-10-22 | Not classified | Other | Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor. | 150 units | 2010-12-16 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2009-10-22 | Not classified | Other | Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor. | 150 units | 2010-12-16 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2009-10-22 | Not classified | Other | Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor. | 150 units | 2010-12-16 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2009-07-14 | Not classified | Software design | incorrect results may be transmitted to LIS | 359 units | 2010-01-05 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2009-06-16 | Not classified | Nonconforming Material/Component | Incorrect result: patient sample BUN results reported may be higher or lower than actual level. | 1254 cartons | 2010-11-30 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2007-07-03 | Not classified | Other | Sample ID and Patient results could be associated with the wrong patient | 72 units | 2007-11-07 |
Recalls
32 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-05-22 | Class II | Under Investigation by firm | Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride. | 1,625 units (1450 US, 175 OUS) | |
| 2024-11-04 | Class II | Software design | Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodiu | 559 units | |
| 2024-10-21 | Class II | Under Investigation by firm | A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patie | 9729 units | |
| 2023-05-16 | Class II | Under Investigation by firm | A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the conditions listed belo | 83 units | |
| 2021-09-28 | Class II | Under Investigation by firm | Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes m | 1193 | |
| 2021-09-28 | Class II | Under Investigation by firm | Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes m | 1733 | |
| 2020-12-02 | Class II | Under Investigation by firm | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results | 1095 units | 2024-06-06 |
| 2020-12-02 | Class II | Under Investigation by firm | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results | 1588 units | 2024-06-06 |
| 2020-05-15 | Class II | Nonconforming Material/Component | Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard | 2925 units | 2022-08-12 |
| 2020-05-15 | Class II | Nonconforming Material/Component | Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard | 1555 units | 2022-08-12 |
| 2020-05-07 | Class II | Employee error | Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers. | 927 | |
| 2020-05-07 | Class II | Employee error | Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers. | 1329 | |
| 2019-09-23 | Class II | Software design | Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher. | 1432 | 2022-07-06 |
| 2019-08-15 | Class II | Under Investigation by firm | Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 | 166 total US: 15; OUS:151 | 2022-05-05 |
| 2019-08-15 | Class II | Under Investigation by firm | Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 | 88 total US: 54;OUS 34 | 2022-05-05 |
| 2018-12-12 | Class II | Under Investigation by firm | When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination. | 5373 | 2020-04-27 |
| 2018-10-16 | Class II | Under Investigation by firm | Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the instrument is aliquotting the sample, the | 1628 | 2020-06-17 |
| 2018-09-28 | Class II | Device Design | Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result in a potential electrical shock | 277 units | 2020-06-17 |
| 2018-06-29 | Class II | Software design | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific R | 35 | 2021-08-12 |
| 2018-06-29 | Class II | Software design | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific R | 107 | 2021-08-12 |
| 2018-06-29 | Class II | Software design | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific R | 5 | 2021-08-12 |
| 2018-06-29 | Class II | Software design | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific R | 115 | 2021-08-12 |
| 2018-06-29 | Class II | Software design | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific R | 92 | 2021-08-12 |
| 2018-06-29 | Class II | Software design | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific R | 45 | 2021-08-12 |
| 2018-02-26 | Class II | Software design | When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers | 2020-05-12 | |
| 2018-02-26 | Class II | Software design | When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers | 2020-05-12 | |
| 2017-02-02 | Class II | Under Investigation by firm | Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may impact all analytes available on the ADV | US: 17 units; Foreign: 712 units | 2018-06-22 |
| 2016-09-29 | Class II | Under Investigation by firm | 448 units | 2018-09-19 | |
| 2016-09-29 | Class II | Under Investigation by firm | Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems. | 448 units | 2018-09-19 |
| 2016-03-30 | Class III | Use error | The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide. | US: 442 units; Foreign: 3237 units | 2017-03-29 |
| 2015-11-10 | Class II | Nonconforming Material/Component | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located | 3 | 2017-08-23 |
| 2015-11-10 | Class II | Nonconforming Material/Component | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container | 151 | 2017-08-23 |
| 2015-11-10 | Class II | Nonconforming Material/Component | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container | 106 | 2017-08-23 |
Source: U.S. FDA establishment registration and device listing records, public domain.
Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.