Bayer Healthcare Llc: Medical Device Recall in 2013 - (Recall #: Z-0136-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 26, 2013

Date Posted: November 13, 2013

Recall Number: Z-0136-2014

Event ID: 66101

Reason for Recall:

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.

Status: Terminated

Product Quantity: 138 Kits in US (Total 2452)

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated