Device recall
Z-0023-2012: VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation…
FDA device recall · Class III · Bio-Rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0023-2012 |
|---|---|
| Recall event | 59868 |
| Product | VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 2 x 1900 mL sodium phosphate buffer 2. Elution… |
| Product code | LCP |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 11, 2012 |
| 510(k) numbers | K991127 |
| 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