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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLH
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