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U.S. Department of Health and Human Services

Class 2 Device Recall AccuChek Go

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  Class 2 Device Recall AccuChek Go see related information
Date Initiated by Firm June 07, 2005
Date Posted August 13, 2005
Recall Status1 Terminated 3 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/
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
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 2
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.