Device recall
Z-2428-2008: Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad…
FDA device recall · Class III · Bio-Rad Laboratories
Key facts
| Recall number (Z-number) | Z-2428-2008 |
|---|---|
| Recall event | 49083 |
| Product | Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette". Catalog #: 30471 - 12 well kit, 60 tests; 30472 - 12 well kit, 240 tests… |
| Product code | DBM |
| Recalling firm | Bio-Rad Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 31, 2011 |
| 510(k) numbers | K810863 |
| FEI number | 3008272466 |
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