Class 3 Device Recall

• Date Initiated by Firm: March 15, 2005
• Date Posted: June 21, 2005
• Recall Status: Terminated on February 10, 2006
• Recall Number: Z-0913-05
• Recall Event ID: 31719
• 510(K)Number: K964721
• Product Classification: Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine - Product Code KLI
• Product: VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
• Code Information: Lot 710, Exp. 7/28/05
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Judy M. Strzepek; 908-218-8524
• Manufacturer Reason for Recall: Potential for positively biased results in QC and patient samples.
• FDA Determined Cause: Other
• Action: Letters dated 3/15/2005 sent First Class Mail. Customers are advised product will be replaced. The letter includes modified quality control procedures that will pre-qualify each reagent pack.
• Quantity in Commerce: Domestic - 1359; International - 840
• Distribution: Nationwide distribution. Product shipped worldwide via J&J foreign affiliates.
• 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 = KLI