Class 2 Device Recall

• Date Initiated by Firm: June 18, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on October 06, 2004
• Recall Number: Z-1063-04
• Recall Event ID: 29329
• 510(K)Number: K030428
• Product Classification: Enzyme Immunoassay, Diphenylhydantoin - Product Code DIP
• Product: Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03516989190.
• Code Information: Lot 14608300.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Technical Support; 800-428-2336
• Manufacturer Reason for Recall: May report falsely decreased patient results.
• FDA Determined Cause: Other
• Action: Consignees were maile a recall letter dated 6/17/04 on 6/18/04 instructing them to cease using this lot and to advise all attending physicians of the problem.
• Distribution: Nationwide, Canada, Germany and Spain.
• 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 = DIP