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U.S. Department of Health and Human Services

Class 3 Device Recall ProSpecT Campylobacter Microplate Assay

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  Class 3 Device Recall ProSpecT Campylobacter Microplate Assay see related information
Date Initiated by Firm July 15, 2002
Date Posted August 17, 2004
Recall Status1 Terminated 3 on December 28, 2006
Recall Number Z-1372-04
Recall Event ID 29672
510(K)Number K982315  
Product Classification Campylobacter Spp. - Product Code LQP
Product ProSpecT Campylobacter Microplate Assay. Catalog #2476096.
Code Information Lot #910718
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 ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
FDA Determined
Cause 2		 Other
Action Remel contacted the customer with a letter, requesting a count of the affected lot, and offered replacement of the kits.
Quantity in Commerce 382
Distribution Entire lot was shipped to one customer in Russelsheim, Germany.
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 = LQP and Original Applicant = ALEXON - TREND, INC.
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