Recall Z-0268-2023 ยท OOI Real Time Nucleic Acid Amplification System
Abbott Molecular, Inc.
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
| Date | Nov 18, 2022 (initiated Oct 12, 2022) |
| Status | Open, Classified |
| Reason | Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position. 2) Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode |
| Root cause | Under Investigation by firm |
| Action | Abbott issued a Filed Correction Recall/Urgent Field Safety Notice to its consignees on October 17, 2022 by FedEx priority overnight express. The letter explained the issues, the potential hazards, and the available actions until mandatory upgrade is completed: 1. In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. Available action: This occurrence was only found in-house under non-standard operating conditions. Prior to instrument use, empty waste container. If waste overflow occurs, please follow internal bio- hazardo |
| Quantity | 883 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.