Device recall
Z-0109-2011: in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test…
FDA device recall · Class II · Bio-Rad Laboratories Inc
Key facts
| Recall number (Z-number) | Z-0109-2011 |
|---|---|
| Recall event | 56762 |
| Product | in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Laboratories, Hercules, CA. The in2it (I) is for Physician use, the (II) is for prescription home use… |
| Product code | LCP |
| Recalling firm | Bio-Rad Laboratories Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2011 |
| 510(k) numbers | K041635 |
| FEI number | 2915274 |
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