Abbott Molecular, Inc. Recall 91001
Description: Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Abbott Molecular, Inc. Recall 91001 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0268-2023 |
| Event ID | 91001 |
| Event Description | Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 883 units |
| Recall 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 in sample prep drawer#2 is scanned. 3) Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RV s) already present in an Amplification Detection Unit (or amp detect) to remain there and not be moved to waste so that more RV s can be placed into the amp detect for processing. 4) 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 separate lots of material which is not detected by the System Control Center (SCC). If this were to occur, the calibration curve would be created using 2 separate material lots. In normal use scenario, this curve would be made using only 1 lot of material. |
| Device Classification | 20221130 |
| Device Code Info | All serial numbers |
| Center Classification Date | 20221118 |
| Recall Initiation Date | 20221012 |
| Recalling Firm | Abbott Molecular, Inc. |
| Initial Notification | Letter |
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