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U.S. Department of Health and Human Services

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

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  Class 3 Device Recall ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay see related information
Date Initiated by Firm July 18, 2002
Date Posted August 17, 2004
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = ALEXON - TREND, INC.
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