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Class 3 Device Recall Premier Toxins A and B |
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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
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Product Classification |
Reagents, Clostridium Difficile Toxin - Product Code LLH
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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/ Manufacturer |
Meridian Bioscience Inc 3471 River Hills Dr Cincinnati OH 45244
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For Additional Information Contact |
513-271-3700 Ext. 229
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Manufacturer Reason for Recall |
The kits were packaged with incorrect dispensing pipettes.
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FDA Determined Cause 2 |
Other |
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
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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 and Original Applicant = MERIDIAN DIAGNOSTICS, INC.
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