Recall Z-0136-2014
Bayer Healthcare Llc · initiated August 26, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot: 1300733 (US, China); Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan)
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Bayer Healthcare sent an Urgent Medical Device Recall letter dated August 26, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and quarantine any affected product. Complete the attached Recall Response Form and fax to Bayer Customer Service. Customers were instructed to use the attached letter to notify affected next level customers of the recall. For questions regarding this recall call 408-524-2255, ext 290.
Details
- Recall number
- Z-0136-2014
- Initiated
- August 26, 2013
- Posted by FDA
- November 2, 2013
- Terminated
- January 14, 2014
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Quantity
- 138 Kits in US (Total 2452)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.
- Recalling firm
- Bayer Healthcare Llc, Sunnyvale, CA