Class 2 Device Recall

• Date Initiated by Firm: July 14, 2004
• Date Posted: July 31, 2004
• Recall Status: Terminated on October 14, 2004
• Recall Number: Z-1303-04
• Recall Event ID: 29550
• 510(K)Number: K864082
• Product Classification: Nadh Oxidation/Nad Reduction, Ast/Sgot - Product Code CIT
• Product: Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138.
• Code Information: Lot 23717132; exp 5/31/2005.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Technical Service; 800-428-4674
• Manufacturer Reason for Recall: Coating defect may result is falsely decreased patient and/or control results.
• FDA Determined Cause: Other
• Action: Recall letters dated 7/14/04 were sent to each customer asking that use of these lots be stopped immediately. Testing labs were asked to notify the attending physician for any patients tested with these test strips.
• Quantity in Commerce: 197 boxes
• Distribution: United States.
• 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 = CIT