Device recall
Z-0018-2012: D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules…
FDA device recall · Class III · Bio-Rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0018-2012 |
|---|---|
| Recall event | 59868 |
| Product | D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC) |
| Product code | LCP |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 11, 2012 |
| 510(k) numbers | K031043 |
| FEI number | 2915274 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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