ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496.
FDA device recall Z-1375-04 · posted 2004-08-17 · Terminated
Recall details
- Recalling firm
- Remel, Inc.
- Reason for recall
- The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
- Action taken
- Remel contacted each customer with a letter, by mail, requesting a count of the affected lots to be returned. Product would be replaced upon customer request.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHI
- Quantity affected
- 127 kits
- Distribution
- US and OUS customers.
- Date initiated
- 2003-12-09
- Date posted
- 2004-08-17
- Date terminated
- 2004-09-15
- Location
- Lenexa, KS
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY (K955157) | Alexon Biomedical, Inc. | 1996-02-09 |