Device recall
Z-1537-2014: Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and…
FDA device recall · Class II · Bio-Rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-1537-2014 |
|---|---|
| Recall event | 68016 |
| Product | Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of… |
| Product code | JPD |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 30, 2014 |
| 510(k) numbers | K991127 |
| FEI number | 2915274 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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