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.
Enforcement
- Recall Number
- Z-0136-2014
- Event ID
- 66101
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Bayer Healthcare Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 13, 2013
- Initiation Date
- August 26, 2013
- Classification Date
- November 1, 2013
- Termination Date
- January 14, 2014
- Address
- 510 Oakmead Pkwy, N/A, Sunnyvale, CA, 94085-4022, United States
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.
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.
Lot: 1300733 (US, China); Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan)
Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.
138 Kits in US (Total 2452)