Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS — Class II medical device recall Z-0136-2014
Terminated recall by Bayer Healthcare Llc, reported 2013-11-13, distributed nationwide. Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined
| Recall number | Z-0136-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare Llc, Sunnyvale, CA, United States |
| Recall initiated | 2013-08-26 |
| Classified | 2013-11-01 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, CN, JP, UY |
| Reason classes | specification failure |
| Lot numbers | 130012, 1300711, 1300712, 1300733 |
| Model numbers | 3021/08842610 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0136-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.