AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management including GTS Plus with Accu-Chek Advantage blood glucose meter, Cat no. 3000249 and/or GTS with Accu-Chek Advantage blood glucose meter, Cat. no. 404, and/or Replacement GTS with Accu-Chek Advantage blood gulcose meter, Cat. no. 404R, and/or Replacement Base Unit with Advantage Module, Cat. no. 3426050. Ref. nos. 030002490001 and 03136833001 both have meters with model no. 777.
FDA Recall Z-1366-06 · Posted 2006-08-05
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Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCGA
Date Initiated2006-06-22
Date Terminated2008-04-07
Product Quantity55,189 meters (for all Recalls Z-1354-1371-06)
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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