Z-0136-2014 Class II Terminated
FDA device recall Z-0136-2014 was initiated by Bayer Healthcare Llc on August 26, 2013 and is designated Class II. 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 … The recall status is terminated (terminated January 14, 2014). Affected quantity: 138 Kits in US (Total 2452).
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2013
- Initiation Date
- August 26, 2013
- Termination Date
- January 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 138 Kits in US (Total 2452)
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.
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.
Code Information
Lot: 1300733 (US, China); Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan)