Recall Z-1456-2022 ยท PDJ Hemoglobin A1c Test System
Abbott Laboratories
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
| Date | Jun 9, 2022 |
| Status | Open, Classified |
| Reason | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay. |
| Root cause | Under Investigation by firm |
| Action | On June 9, 2022, Abbott issued a "Urgent Medical Device Correction" to affected consignees via FedEx. 1. Immediately install the updated assay file versions listed below (as applicable for your laboratory), and manually configure the Low-Linearity value. The assay files can be obtained from www.corelaboratory.abbott 2. For the whole blood application, manually configure the THbWB Low-Linearity to 53.8278. For the hemolysate application, manually configure the THbH Low-Linearity to 1250. For detailed information on editing assay parameters, refer to Changing assay configuration settings, Chan |
| Quantity | 64 units |
| Distribution | US: AK AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NJ NV NY OH OK OR PA PR SC SD TN TX UT VA WA WI WV OUS: ALBANIA ALGERIA ANDORRA ANGOLA ARGENTINA ARMENIA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BANGLADESH BELARUS BELGIUM BERMUDA BOSNIA AND HERZEGOVI BRAZIL BRUNEI BULGA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.