Class 3 Device Recall

• Date Initiated by Firm: July 18, 2003
• Date Posted: September 12, 2003
• Recall Status: Terminated on May 17, 2004
• Recall Number: Z-1202-03
• Recall Event ID: 26829
• Product Classification: Nad-Nadh, Specific Reagent For Alcohol Enzyme Method - Product Code DML
• Product: On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464 Roche Diagnostics Label A305-02 Varian, Inc. label
• Code Information: None given.
• FEI Number: 2026835
• Recalling Firm/ Manufacturer: Varian, Inc.; 25200 Commercentre Drive; Lake Forest CA 92630-8810
• For Additional Information Contact: Lorna Gamboa; 800-854-0277
• Manufacturer Reason for Recall: Stability in question.
• FDA Determined Cause: Other
• Action: Recall letter was sent on July 18, 2003 which instructs to stop using affected product and return it for free replacement.
• Quantity in Commerce: 11847 kits (50 units/kit)
• Distribution: Nationwide
• 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.