Home / Recalls / Medical Devices
Bayer Healthcare Llc recalls Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated He
Recalled November 13, 2013 · FDA recall Z-0136-2014 · Bayer Healthcare
Hazard
Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release. · FDA Class II
Units
138 Kits in US (Total 2452)
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.
Description
Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.
Product
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.
Manufacturer(s)
Bayer Healthcare Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →