Device recall
Z-0867-2010: Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by…
FDA device recall · Class II · Bio-Rad Laboratories Inc
Key facts
| Recall number (Z-number) | Z-0867-2010 |
|---|---|
| Recall event | 53649 |
| Product | Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. Intended Use: For the percent 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 II |
| Status | Terminated |
| Termination date | Dec 17, 2010 |
| 510(k) numbers | 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