Device recall
Z-0021-2012: VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in…
FDA device recall · Class III · Bio-Rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0021-2012 |
|---|---|
| Recall event | 59868 |
| Product | VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation… |
| Product code | LCP |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 11, 2012 |
| 510(k) numbers | K040872 |
| 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