Device recall
Z-1589-2008: VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number…
FDA device recall · Class II · Bio-Rad Laboratories Inc
Key facts
| Recall number (Z-number) | Z-1589-2008 |
|---|---|
| Recall event | 47421 |
| Product | VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104 |
| Product code | JPD |
| Recalling firm | Bio-Rad Laboratories Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 10, 2009 |
| 510(k) numbers | K924122 |
| 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