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U.S. Department of Health and Human Services

Class 2 Device Recall Premier Toxin A

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  Class 2 Device Recall Premier Toxin A see related information
Date Initiated by Firm December 26, 2002
Date Posted January 23, 2003
Recall Status1 Terminated 3 on March 29, 2004
Recall Number Z-0463-03
Recall Event ID 25295
510(K)Number k926442  
Product Classification Antigen, C. Difficile - Product Code MCB
Product Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box.
Code Information Lot #601096.180, Exp Date 27 SEP 03;  Kit Catalog #601096.
Recalling Firm/
Manufacturer
Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244
Manufacturer Reason
for Recall
Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
FDA Determined
Cause 2
Other
Action The firm mailed notices to their affected customers on 12/26/2002. The consignees were instructed to visually and physically inspect the seals on each microwell pouch for gaps. If properly sealed, the use of the microwells may be continued. Test wells in pouches with defective seals are to be quarantined and destroyed. The customers are asked to report back to the firm. All test microwell plates in defective pouches will be replaced by the firm.
Quantity in Commerce 1,215 kits
Distribution The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan.
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 = MCB and Original Applicant = MERIDIAN DIAGNOSTICS, INC.
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