Recall Z-1373-04 ยท GMZ Antigens, All Types, Escherichia Coli
Remel, Inc.
ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures.
| Date | Aug 17, 2004 (initiated Jul 18, 2002) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 83 (15-2474048, 68-2474096) |
| Distribution | US and OUS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980507 | PROSPECT SHIGA TOXIN MICROPLATE ASSAY Alexon - Trend, Inc., Apr 23, 1998 |