Device recall
Z-2982-2020: BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema…
FDA device recall · Class II · Bio-Rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-2982-2020 |
|---|---|
| Recall event | 85636 |
| Product | BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin… |
| Product code | LIP |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K170413 |
| 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