Device recall
Z-1743-2019: MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is…
FDA device recall · Class II · Bio-Rad Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-1743-2019 |
|---|---|
| Recall event | 82761 |
| Product | MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. |
| Product code | JSO |
| Recalling firm | Bio-Rad Laboratories, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 30, 2020 |
| 510(k) numbers | K171061 |
| 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