Device recall
Z-1650-2011: BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 The BioPlex 2200…
FDA device recall · Class II · Bio-Rad Laboratories
Key facts
| Recall number (Z-number) | Z-1650-2011 |
|---|---|
| Recall event | 57404 |
| Product | BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis IgG Reagent Pack in the clinical laboratory. |
| Product code | LIP |
| Recalling firm | Bio-Rad Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2011 |
| 510(k) numbers | K063866 |
| 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