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.
FDA Recall Z-1373-04 · Posted 2004-08-17
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Recalling FirmRemel, Inc.
Recall StatusTerminated
Product CodeGMZ
Date Initiated2002-07-18
Date Terminated2004-09-15
Product Quantity83 (15-2474048, 68-2474096)
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.
Firm 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.
Root Cause
Other
Distribution Pattern
US and OUS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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