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U.S. Department of Health and Human Services

Class 3 Device Recall Premier Toxins A and B

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  Class 3 Device Recall Premier Toxins A and B see related information
Date Initiated by Firm September 23, 2003
Date Posted October 24, 2003
Recall Status1 Terminated 3 on March 29, 2004
Recall Number Z-0062-04
Recall Event ID 27346
510(K)Number k993914  
Product Classification Reagents, Clostridium Difficile Toxin - Product Code LLH
Product Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.
Code Information Lots 616096.095, -096, and -097. Expiration Date: 23 Jul 03.
Recalling Firm/
Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244
For Additional Information Contact
513-271-3700 Ext. 229
Manufacturer Reason
for Recall
The kits were packaged with incorrect dispensing pipettes.
FDA Determined
Cause 2
Action The firm notified their affected consignees by letter on 9/23/2003.
Quantity in Commerce 2030 kits
Distribution The kits were shipped to consignees located nationwide, and into New Zealand, Haiti, Belgium, Italy, Brazil, Australia, Canada, and Chile.
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 = LLH and Original Applicant = MERIDIAN DIAGNOSTICS, INC.