Device recall
Z-1647-2011: Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests, Catalog No. 96DS…
FDA device recall · Class II · Bio-Rad Laboratories Inc
Key facts
| Recall number (Z-number) | Z-1647-2011 |
|---|---|
| Recall event | 56044 |
| Product | Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests, Catalog No. 96DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Bio-Rad Autoimmune EIA Anti-dsDNA Test is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of dsDNA antibodies in… |
| Product code | LRM |
| Recalling firm | Bio-Rad Laboratories Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 15, 2011 |
| 510(k) numbers | K960091 |
| 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