Alinity
Alinity ci-series Calibrator/Control Replacement Caps
16manufacturers in China registered for this device type
18catalogue numbers in this listing
13510(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 | Abbott Laboratories, 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 | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-05-31 |
| Record revised | 2024-01-03 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 15 to 30 °C |
| Distribution end date | 2022-06-10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 03R6701 | In distribution | ||
| 08P9781 | In distribution | ||
| 08P9670 | In distribution | ||
| 08P7840 | In distribution | ||
| 04S1740 | 10 | In distribution | |
| 01R3801 | 1,000 | In distribution | |
| 06P1401 | 4,000 | In distribution | |
| 01R6070 | In distribution | ||
| 04S1750 | 10 | In distribution | |
| 04R4701 | 100 | In distribution | |
| 02R5250 | 2 | In distribution | |
| 03R7001 | In distribution | ||
| 08P9871 | In distribution | ||
| 01R5950 | 2 | In distribution | |
| 04R1001 | 100 | In distribution | |
| 08P7740 | In distribution | ||
| 03R6501 | In distribution | ||
| 08P9780 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alinity | Abbott Medical | 283 |
| Architect | Abbott Laboratories | 115 |
| 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 |
| Vidas 3 | bioMerieux, Inc. | 3 |
Showing 12 of 336. All products under Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K974779 | 1998-02-13 |
| K974651 | 1998-02-12 |
| K945566 | 1995-06-09 |
| K950915 | 1995-05-16 |
| K894222 | 1989-09-28 |
| K893776 | 1989-08-03 |
| K882914 | 1988-08-30 |
| K882913 | 1988-08-30 |
| K854936 | 1986-02-06 |
| K844114 | 1984-11-27 |
| K841916 | 1984-06-22 |
| K782014 | 1979-01-10 |
| K771345 | 1977-08-04 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Abbott Laboratories | UDI-DI | 2025-11-13 | Class II | Software design | Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software version | 11653 |
| Abbott Laboratories | UDI-DI | 2023-05-30 | Class II | Software design | There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism | 8,424 |
| Abbott Laboratories | UDI-DI | 2022-11-24 | Class III | Material/Component Contamination | Reaction vessels may contain a potential contaminant that could affect their optical performance. | 70 cases |
Recalls
19 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-10-19 | Class II | Under Investigation by firm | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). | 1,127 systems | |
| 2023-10-19 | Class II | Under Investigation by firm | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). | 1,325 systems | |
| 2023-10-19 | Class II | Under Investigation by firm | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). | 995 systems | |
| 2021-09-29 | Class II | Software design | Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing | 20,994 systems | |
| 2021-09-29 | Class II | Software design | Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing | 7,535 systems | |
| 2021-07-26 | Class II | Software design | Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the | 4,833 systems | |
| 2019-05-01 | Class II | Device Design | Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed. | 09D59-01, 1010 products, 09D59-02, 25156 products, 09D59-03 | 2021-07-02 |
| 2018-07-17 | Class II | Software design | There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status. | 1,666 instruments | 2020-09-23 |
| 2018-07-17 | Class II | Software design | There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status. | 3,675 instruments | 2020-09-23 |
| 2018-07-17 | Class II | Software design | There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status. | 3,794 instruments | 2020-09-23 |
| 2017-12-08 | Class II | Device Design | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument. | 3,634 ARCHITECT c4000 systems | 2019-07-11 |
| 2017-12-08 | Class II | Device Design | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument. | 3,357 ARCHITECT c8000 Systems | 2019-07-11 |
| 2017-12-08 | Class II | Device Design | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument. | 1,560 ARCHITECT c16000 Systems | 2019-07-11 |
| 2017-09-29 | Class II | Component design/selection | The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector. | 44 units | |
| 2017-09-29 | Class II | Component design/selection | The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector. | 34 units | |
| 2015-09-09 | Class II | Nonconforming Material/Component | Incorrect tubing. | 65 units | 2016-11-17 |
| 2015-06-11 | Class II | Mixed-up of materials/components | The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak. | 5 units | 2016-02-09 |
| 2015-05-11 | Class II | Under Investigation by firm | The product is leaking from the cap and crystallization was noted as present around the cap. | 8868 units | 2016-06-27 |
| 2015-01-15 | Class II | Device Design | There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument. | 1,385 cuvette segments | 2020-07-20 |
| 2009-09-11 | Not classified | Software design | ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters. | 11 in the USA; 104 worldwide | 2011-01-25 |
| 2009-07-17 | Not classified | Other | Under certain conditions, the product’s wash buffer containing sodium azide can come in contact with the wash zone mechanism ground cables on either of the two wash zones. The copper in the ground strap may corrode and form an unstable che | 4,526 | 2010-01-26 |
| 2009-04-24 | Not classified | Software change control | There continues to be an elevated level of complaint activity for calibration error code 1227, when using ARCHITECT LH reagent lots (6C25-22 or 6C25-27) due to the use of assay disk versions that do not contain the updated ARCHITECT LH assa | 1,037CD-ROMs – US, 4,676 CD-ROMs – WW | 2009-11-30 |
| 2009-02-26 | Not classified | Nonconforming Material/Component | Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test, background read failure), error code 1007 (unable to process test, activated read failure) and incorrect results when using these lots o | 27,163 cartons | 2010-11-04 |
| 2009-02-18 | Not classified | Manufacturing material removal | Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date. | 1,965 kits | 2010-07-08 |
| 2008-10-21 | Not classified | Mixed-up of materials/components | During manufacturing, two components of the ARCHITECT i1000SR were reversed which could potentially cause falsely elevated patient results due to a sample-reagent and reagent-sample carryover. | 404 units distributed worldwide (including US) | 2012-04-13 |
| 2008-06-16 | Not classified | Software design | When running the Automated Dilution Protocol with the assay files “CMV IgG” or “Toxo IgG” on the ARCHITECT i1000SR system, a software error [9010 (Pipettor Robotics) preventing (Process Path) from operating] is generated and the instrument | 75 CD-ROMs | 2010-03-18 |
| 2007-09-05 | Not classified | Software change control | Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of | 89 units. | 2010-10-04 |
| 2007-09-05 | Not classified | Software change control | Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of | 2070 units. | 2010-10-04 |
| 2007-04-30 | Not classified | Other | One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring | 23 units. | 2008-03-19 |
| 2007-04-30 | Not classified | Other | One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring | 2,072 units. | 2008-03-19 |
| 2007-04-30 | Not classified | Other | One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring | 1,079 units. | 2008-03-19 |
| 2007-04-30 | Not classified | Other | One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring | 170 units. | 2008-03-19 |
| 2007-03-28 | Not classified | Other | If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results. | n/a | 2007-09-25 |
| 2007-03-28 | Not classified | Other | If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results. | n/a | 2007-09-25 |
| 2006-12-12 | Not classified | Other | The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature control function of the b | 648 units. | 2007-09-24 |
| 2006-12-12 | Not classified | Other | The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature control function of the b | 57 units. | 2007-09-24 |
| 2005-12-08 | Not classified | Other | System software assigns a calibrator default volume of 2.0uL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL. | 1206 units. | 2007-09-25 |
| 2005-09-14 | Not classified | Other | Software deficiency causing potential shift in absorbance readings for test results. | 1,107 units | 2007-09-25 |
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.