Class 3 Device Recall ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay

• Date Initiated by Firm: July 18, 2002
• Date Posted: August 17, 2004
• Recall Status: Terminated on September 15, 2004
• Recall Number: Z-1373-04
• Recall Event ID: 29677
• 510(K)Number: K980507
• Product Classification: Antigens, All Types, Escherichia Coli - Product Code GMZ
• 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.
• Code Information: 918706 918707
• FEI Number: 1924669
• Recalling Firm/ Manufacturer: Remel, Inc.; 12076 Santa Fe Trail Dr; (PO Box 14478, zip 66285-4478); Lenexa KS 66215-3519
• Manufacturer 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.
• FDA Determined 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 in Commerce: 83 (15-2474048, 68-2474096)
• Distribution: US and OUS.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GMZ