Device recall
Z-0908-2010: Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative…
FDA device recall · Class III · Bio-Rad Laboratories
Key facts
| Recall number (Z-number) | Z-0908-2010 |
|---|---|
| Recall event | 49449 |
| Product | Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052 For the qualitative, semi-quantitative and quantitative detection of human… |
| Product code | LFX |
| Recalling firm | Bio-Rad Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 8, 2010 |
| 510(k) numbers | K961053 |
| FEI number | 3008272466 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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