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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 18, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 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/
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Technical Support
Manufacturer Reason
for Recall
May report falsely decreased patient results.
FDA Determined
Cause 2
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 and Original Applicant = ROCHE DIAGNOSTICS CORP.