Class 3 Device Recall

• Date Initiated by Firm: August 20, 2004
• Date Posted: September 02, 2004
• Recall Status: Terminated on November 05, 2004
• Recall Number: Z-1435-04
• Recall Event ID: 29893
• Product Classification: Nadh Oxidation/Nad Reduction, Ast/Sgot - Product Code CIT
• Product: Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216).
• Code Information: All lots expiring on or before 7/05.
• FEI Number: 1823260
• 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: Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.
• FDA Determined Cause: Other
• Action: Consignees were mailed recall notices dated 8/20/04 and were instructed to either reduce the initial reagent bottle volume prior to use, or to request replacement product.
• Quantity in Commerce: 757non-expired kits.
• 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.