Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST D
FDA device recall Z-0659-05 · posted 2005-03-29 · Terminated
Recall details
- Recalling firm
- Bio Rad Laboratories, Inc.
- Reason for recall
- New instructions to recommend against using samples with visibly high level of blood.
- Action taken
- Letters were sent to customers January 25-27, 2005 via overnight mail. Letters advised the customers of the issue and included a new package insert. The firm included a revised package insert to clarify precautions. The firm sent a CORRECTED COPY letter dated January 31, 2005 outlining the changes made in the product insert.
- Root cause
- Other
- Status
- Terminated
- Product code
- NOM
- Quantity affected
- 1547 kits
- Distribution
- Product was distributed to 93 hospitals and medical centers located throughout the US
- Date initiated
- 2005-01-25
- Date posted
- 2005-03-29
- Date terminated
- 2005-04-21
- Location
- Redmond, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT (K870176) | Genetic Systems Corp. | 1987-07-16 |