Class 3 Device Recall Premier Toxins A and B

• Date Initiated by Firm: September 23, 2003
• Date Posted: October 24, 2003
• Recall Status: Terminated on March 29, 2004
• Recall Number: Z-0062-04
• Recall Event ID: 27346
• 510(K)Number: K993914
• Product Classification: Reagents, Clostridium Difficile Toxin - Product Code LLH
• 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
• For Additional Information Contact: 513-271-3700 Ext. 229
• Manufacturer Reason for Recall: The kits were packaged with incorrect dispensing pipettes.
• FDA Determined Cause: 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

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