Class 2 Device Recall Premier CMV IgG Elisa Kits

• Date Initiated by Firm: June 18, 2003
• Date Posted: August 12, 2003
• Recall Status: Terminated on March 29, 2004
• Recall Number: Z-1127-03
• Recall Event ID: 26505
• 510(K)Number: k924096
• Product Classification: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus - Product Code LFZ
• Product: Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.
• Code Information: Lot Numbers: #03022371 and #03022472. All lots Exp Date: 2004-07.
• Recalling Firm/ Manufacturer: Meridian Bioscience Inc; 3471 River Hills Dr; Cincinnati OH 45244
• For Additional Information Contact: 513-271-3700
• Manufacturer Reason for Recall: The Low Positive Standard kit component is losing potency that may result in false positive test results.
• FDA Determined Cause: Other
• Action: The firm notified their customers by telephone and fax on 6/18/2003.
• Quantity in Commerce: 43 kits
• Distribution: The kits were shipped to end-users located in CA, UT, NY, MD, KY; and to a foreign distributor in Belgium.
• 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 = LFZ and Original Applicant = ZEUS SCIENTIFIC, INC.