REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Check against the official notice below — it lists the full affected range.
Abbott Laboratories is recalling a hemoglobin A1c test reagent kit (REF: 4P52-20) used with ARCHITECT and Alinity c hemoglobin A1c assay machines. The recall affects 103,316 units distributed across the United States, Puerto Rico, and numerous countries worldwide. The problem is that the reagent has the potential to generate falsely elevated hemoglobin A1c and hemoglobin %A1c results.
The affected lots are: 59588UQ04, 59868UQ05, 59900UQ06, 60138UQ07, 60237UQ08, 60535UQ08, 60698UQ09, 60880UQ10, 61066UQ11, 61246UQ01, and 61250UQ01. The source document 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: 103,316 Lot/code info: UDI/DI: 00380740102746/ Lots: 59588UQ04, 59868UQ05, 59900UQ06, 60138UQ07, 60237UQ08, 60535UQ08, 60698UQ09, 60880UQ10, 61066UQ11, 61246UQ01, 61250UQ01
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.