Device recall
Z-2889-2011: D-10 Dual Program Reorder Pack; contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits…
FDA device recall · Class III · Bio-Rad Laboratories Inc
Key facts
| Recall number (Z-number) | Z-2889-2011 |
|---|---|
| Recall event | 59346 |
| Product | D-10 Dual Program Reorder Pack; contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2. Bio-Rad Laboratories Inc. Hercules, CA. Product Usage: Short Proghram: D-10 Dual Program is intended for the percent determination of hemoglobin A1c in human whole blood… |
| Product code | LCP |
| Recalling firm | Bio-Rad Laboratories Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 12, 2012 |
| 510(k) numbers | K041444 |
| 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