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Medical Device Recalls
Class 1 Recall: CoaguChek PT Test Strips
See Related Information
Date Recall
Initiated:
 September 12, 2003
Product:
 CoaguChek brand PT test strips; U.S. catalog number 3116247, lot numbers 591 and 619.
Use:
 CoaguChek PT test strips are used by patients in the home and by professionals in medical settings to determine blood clotting time of patients taking anti-coagulants, also known as blood thinners, and to diagnose some disease conditions.
Recalling Firm:
 Roche Diagnostics Corp.
9115 Hague Road
Indianapolis, IN
46250-0457
Reason for Recall:
 Roche has determined that some of the foil pouches in which the test strips are packaged were improperly sealed allowing moisture and air to enter the pouch. These products give false results when exposed to moisture for more than a few minutes.
Public Contact:
 Roche Diagnostics Point of Care Technical Service
1-800-428-4674, 24 hours a day, 365 days a year
FDA District:
 Detroit
FDA Comment:
 Use of the defective strips may have serious or life threatening consequences.
 

For additional information on this product recall, see the Office of In-Vitro Diagnostic Device Evaluation and Safety (OIVD) webpage at: http://www.fda.gov/cdrh/oivd/news.html.

Also, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2003/ENF00817.html. Scroll down to "Recalls and Field Corrections: Devices – Class I".

Updated October 16, 2003

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