Device recall
Z-0965-2014: D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United…
FDA device recall · Class III · Bio-Rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0965-2014 |
|---|---|
| Recall event | 66947 |
| Product | D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F… |
| Product code | LCP |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 20, 2014 |
| 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