Reported Nov 13, 2013 · Terminated
Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated…
Bayer Healthcare LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer Healthcare Llc · 510 Oakmead Pkwy · Sunnyvale, CA · 94085-4022
Is this the product you have?
- 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.
- Lot codes and dates
- Lot1300733 (US, China)
- Lot1300712 (Argentina, Uruguay)
- Lots
1300711130012 (Japan)
- Amount recalled
- 138 Kits in US (Total 2452)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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