ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). Fo
FDA device recall Z-1373-04 · posted 2004-08-17 · Terminated
Recall details
- Recalling firm
- Remel, Inc.
- Reason for recall
- A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
- 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
- GMZ
- Quantity affected
- 83 (15-2474048, 68-2474096)
- Distribution
- US and OUS.
- Date initiated
- 2002-07-18
- 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 SHIGA TOXIN MICROPLATE ASSAY (K980507) | Alexon - Trend, Inc. | 1998-04-23 |