Device Recall Bayer brand A1CNow MULTITEST A1C SYSTEM TEST KITS

Lot: 1300733 (US, China);  Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan)

Hematology and Pathology Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.

Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by || Bayer HealthCare LLC, Sunnyvale, CA || The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.