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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