Device recall
Z-1969-2011: Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update…
FDA device recall · Class III · Bio-Rad Laboratories, Inc., Hercules, CA
Key facts
| Recall number (Z-number) | Z-1969-2011 |
|---|---|
| Recall event | 56807 |
| Product | Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA System Overview: The Bio-Rad D-10 Hemoglobin… |
| Product code | LCP |
| Recalling firm | Bio-Rad Laboratories, Inc., Hercules, CA |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 29, 2011 |
| 510(k) numbers | K031043 |
| 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