Platelia Aspergillus EIA
FDA device recall Z-0348-04 · posted 2004-01-14 · Terminated
Recall details
- Recalling firm
- Bio Rad Laboratories, Inc.
- Reason for recall
- Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.
- Action taken
- Customers were sent a letter, Technical Bulletin and revised package insert on November 6, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- NOM
- Quantity affected
- 147 kits
- Distribution
- The firm distributed to hospitals and diagnostic laboratories nationwide.
- Date initiated
- 2003-11-06
- Date posted
- 2004-01-14
- Date terminated
- 2004-01-27
- 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 |
|---|---|---|
| PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 (K023857) | Bio-Rad | 2003-05-16 |