Class 2 Device Recall AccuChek Go

• Date Initiated by Firm: June 07, 2005
• Date Posted: August 13, 2005
• Recall Status: Terminated on July 02, 2007
• Recall Number: Z-1370-05
• Recall Event ID: 32100
• 510(K)Number: K040796
• Product Classification: System, Test, Blood Glucose, Over The Counter - Product Code NBW
• Product: ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.
• Code Information: All units.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-440-3638
• Manufacturer Reason for Recall: The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards, and held upwards, while the meter is waiting for the sample.
• FDA Determined Cause: Other
• Action: Recall letters dated 6/7/05 were sent to all customers. Distributors were requested to send a copy of the notification to all customers of test strips used with the product. Users are instructed to never operate the meter without the optics cover in place, and this information will be included in test strip boxes.
• Quantity in Commerce: 2490
• 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 and Original Applicant = ROCHE DIAGNOSTICS CORP.