Device recall
Z-0235-2022: BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack…
FDA device recall · Class II · Bio-Rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0235-2022 |
|---|---|
| Recall event | 88874 |
| Product | BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of… |
| 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