Drug recall
Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor…
FDA recall event 66101 · Class II · Bayer Healthcare Llc
Key facts
| Event ID | 66101 |
|---|---|
| Recall numbers | Z-0136-2014 |
| Recalling firm | Bayer Healthcare Llc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 26, 2013 |
| Report date | Nov 13, 2013 |
| Termination date | Jan 14, 2014 |
| City | Sunnyvale |
| State | CA |
| Country | United States |
| FEI number | 3000206585 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: