—#34333

Product

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 product code: GMZ — Antigens, All Types, Escherichia Coli
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K980507
Affected lot / code info: 918706 918707

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Remel, Inc.
Address: 12076 Santa Fe Trail Dr (PO Box 14478, zip 66285-4478), Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: US and OUS.

Timeline

Recall initiated: 2002-07-18
Posted by FDA: 2004-08-17
Terminated: 2004-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34333. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.