Device recall
Z-0136-2014: Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610)…
FDA device recall · Class II · Bayer Healthcare Llc
Key facts
| Recall number (Z-number) | Z-0136-2014 |
|---|---|
| Recall event | 66101 |
| 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… |
| Product code | LCP |
| Recalling firm | Bayer Healthcare Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 14, 2014 |
| 510(k) numbers | K090413 |
| FEI number | 3000206585 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database