Device recall
Z-0122-2011: in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c…
FDA device recall · Class II · Bio-Rad Laboratories Inc
Key facts
| Recall number (Z-number) | Z-0122-2011 |
|---|---|
| Recall event | 56503 |
| Product | in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer, manufactured by Bio-Rad, Flintshire, UK The in2it (I) and (II) is an affinity chromatography method and is intended for the in-vitro… |
| Product code | LCP |
| Recalling firm | Bio-Rad Laboratories Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 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