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U.S. Department of Health and Human Services

Class 2 Device Recall ImmunoCard toxins A & B kit

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  Class 2 Device Recall ImmunoCard toxins A & B kit see related information
Date Initiated by Firm June 02, 2006
Date Posted July 04, 2006
Recall Status1 Terminated 3 on February 16, 2012
Recall Number Z-1203-06
Recall Event ID 35604
510(K)Number K041003  
Product Classification Reagents, Clostridium Difficile Toxin - Product Code LLH
Product ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic.
Code Information Lot 712050.066, expiration date 2007-02-22 and Lot 712050.068, expiration date 2007-03-08.
Recalling Firm/
Manufacturer		 Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244-3023
For Additional Information Contact Michelle Smith
513-271-3700
Manufacturer Reason
for Recall		 The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates.
FDA Determined
Cause 2		 Other
Action The recalling firm sent a recall letter dated 6/2/06 to their customers.
Quantity in Commerce 704
Distribution Nationwide.
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 BIOSCIENCE, INC.
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