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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 Bsee related information
Date Initiated by FirmSeptember 23, 2003
Date PostedOctober 24, 2003
Recall Status1 Terminated 3 on March 29, 2004
Recall NumberZ-0062-04
Recall Event ID 27346
510(K)NumberK993914 
Product Classification Reagents, Clostridium Difficile Toxin - Product Code LLH
ProductPremier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.
Code Information Lots 616096.095, -096, and -097. Expiration Date: 23 Jul 03.
FEI Number 1524213
Recalling Firm/
Manufacturer		 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		Other
ActionThe firm notified their affected consignees by letter on 9/23/2003.
Quantity in Commerce2030 kits
DistributionThe kits were shipped to consignees located nationwide, and into New Zealand, Haiti, Belgium, Italy, Brazil, Australia, Canada, and Chile.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLH
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