Device 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.
Z-0136-2014
Product summary
- Event
- Event 66101
- Status
- Terminated
- Classification
- Class II
- Quantity
- 138 Kits in US (Total 2452)
- Official record key
device-enforcement:Z-0136-2014
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.