Device recall
Z-0659-05: Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT…
FDA device recall · Class II · Bio Rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0659-05 |
|---|---|
| Recall event | 31123 |
| Product | Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.S. by Bio-Rad Laboratories Diagnostics Group 6565 185th Avenue NE, Redmond, WA 98052-5039. Side of kit states Bio-Rad 3, boulevard Raymond… |
| Product code | NOM |
| Recalling firm | Bio Rad Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 21, 2005 |
| 510(k) numbers | K870176 |
| FEI number | 3008272466 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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