Recall Z-2472-2021 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
| Date | Jul 26, 2021 |
| Status | Open, Classified |
| Reason | 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 Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process tes |
| Root cause | Software design |
| Action | On 07/26/2021, the firm sent an "Product Correction Urgent-Immediate Action Required" Notification Letter via FedEx priority overnight express informing customers that the Recalling Firm identified three potential performance issues with software version 3.2.3 and earlier and that the Recalling Firm is releasing software version 3.3.0 to correct the following issues: 1. There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of OK . In this scenario, the expired reagent will rem |
| Quantity | 4,833 systems |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico; Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.