Device recall
Z-1145-2010: BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02…
FDA device recall · Class III · Bio-Rad Laboratories Inc
Key facts
| Recall number (Z-number) | Z-1145-2010 |
|---|---|
| Recall event | 52889 |
| Product | BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591". in vitro diagnostic. |
| Product code | DHC |
| Recalling firm | Bio-Rad Laboratories Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 18, 2011 |
| 510(k) numbers | K032868 |
| 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