Device recall
Z-1342-2011: Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model…
FDA device recall · Class III · Bio-Rad Laboratories Inc
Key facts
| Recall number (Z-number) | Z-1342-2011 |
|---|---|
| Recall event | 56387 |
| Product | Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423, Distributed and Manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA. Intended for the percent determination of hemoglobin… |
| Product code | LCP |
| Recalling firm | Bio-Rad Laboratories Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 4, 2011 |
| 510(k) numbers | K040872, K063400 |
| 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