Device recall
Z-0236-2022: BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The…
FDA device recall · Class II · Bio-Rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0236-2022 |
|---|---|
| Recall event | 88874 |
| Product | BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack. |
| 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