Atellica CH EMPTY2
Catalogue number 11538115, listed by Siemens Healthcare Diagnostics Inc, United States, under Analyzer, Chemistry (Photometric, Discrete), For Clinical Use. 16 manufacturers in China are registered for this product code.
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) | K151767 |
| Record published | 2021-02-05 |
| Record revised | 2022-01-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 30 °C; Storage environment temperature 2 to 30 °C; Special storage condition: Store Upright |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 11538115 | 8 | 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
3 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 | 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) | |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 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 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 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 |
Recalls
36 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 |
|---|---|---|---|---|---|
| 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 | |
| 2021-10-15 | Class II | Software design | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays | 1326 units | 2024-05-13 |
| 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 |
| 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 | |
| 2019-08-15 | 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 |
| 2018-12-12 | 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 |
| 2018-10-16 | 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 |
| 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 | 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 | |
| 2017-03-03 | 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 |
| 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 |
| 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 |
| 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 |
| 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 | 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 | 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.
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