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
Check against the official notice below — it lists the full affected range.
Abbott Laboratories is recalling 64 units of the Alinity c Hemoglobin Reagent Kit (reference 08P4377) with lots 59801UQ04 and 60763UQ09 due to a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results when used with ARCHITECT and Alinity c Hemoglobin A1c assays. The affected reagent kits contain R1 (5 x 46.0 mL), R2 (5 x 18.3 mL), and A1cDL (5 x 67.6 mL) components and have been distributed across the United States, multiple U.S. territories, Canada, and numerous countries worldwide including Europe, Asia, South America, Africa, and Australia.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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 BULGARIA BURKINA FASO CANADA CHILE CHINA COLOMBIA COSTA RICA Country CROATIA CYPRUS CZECH REPUBLIC ECUADOR Quantity: 64 units Lot/code info: UDI/DI: 00380740174989/ Lots: 59801UQ04 and 60763UQ09
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.