REF: 08P4320, 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 7,391 units of the Alinity c Hemoglobin Reagent Kit (reference 08P4320) distributed across the United States, Puerto Rico, and multiple international locations. The reagent kit, which is used with ARCHITECT and Alinity c analyzers to measure hemoglobin A1c levels, may produce falsely elevated test results. The affected product lots are 59561UQ04, 59779UQ05, 60229UQ07, 60540UQ09, 61011UQ10, 61349UQ01, and 61658UQ01.
The recall notice does not specify a remedy or recommended action for affected consumers or healthcare providers.
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: 7,391 units Lot/code info: UDI/DI: 00380740135591/ Lots: 59561UQ04, 59779UQ05, 60229UQ07, 60540UQ09, 61011UQ10, 61349UQ01, 61658UQ01
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.