Class 2 Device Recall

• Date Initiated by Firm: November 19, 2004
• Date Posted: December 28, 2004
• Recall Status: Terminated on June 07, 2005
• Recall Number: Z-0372-05
• Recall Event ID: 30462
• 510(K)Number: K012210
• Product Classification: System, Test, Blood Glucose, Over The Counter - Product Code NBW
• Product: ACCU-CHEK Inform meter; catalog No. 3035123.
• Code Information: All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.
• FEI Number: 1823260
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-440-3638
• Manufacturer Reason for Recall: A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.
• FDA Determined Cause: Other
• Action: Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality.
• Quantity in Commerce: 4697
• 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.

• 510(K) Database: 510(K)s with Product Code = NBW