RecallDepth

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.

This recall has been terminated (originally issued August 17, 2004).

Company
Remel Inc
Recall Initiated
July 18, 2002
Posted
August 17, 2004
Terminated
September 15, 2004
Recall Number
Z-1373-04
Quantity
83 (15-2474048, 68-2474096)
Firm Location
Lenexa, KS
Official Source
View on FDA website ↗

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.

Distribution

US and OUS.

Lot / Code Info

918706 918707

Root Cause

Other

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.

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