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U.S. Department of Health and Human Services

Class 2 Device Recall GTS Advantage

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  Class 2 Device Recall GTS Advantage see related information
Date Initiated by Firm June 22, 2006
Date Posted August 05, 2006
Recall Status1 Terminated 3 on April 07, 2008
Recall Number Z-1368-06
Recall Event ID 35022
510(K)Number K924475  
Product Classification Blood Glucose Meter - Product Code CGA
Product GTS Advantage Meter. Cat. no. 424. Ref. no. 03144780001 with meter model no. 777.
Code Information All units.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46250-0416
For Additional Information Contact
800-440-3638
Manufacturer Reason
for Recall		 The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.
FDA Determined
Cause 2		 Other
Action A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available.
Quantity in Commerce 55,189 meters (for all Recalls Z-1354-1371-06)
Distribution Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
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 = CGA and Original Applicant = BOEHRINGER MANNHEIM CORP.
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