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U.S. Department of Health and Human Services

Safety

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CoaguChek PT test strips

Audience: Primary Care providers and consumers

The FDA Center for Devices and Radiological Health posted a Class I recall notice for CoaguChek PT test strips, used by patients in the home and by professionals in medical settings to determine blood clotting time of patients taking anti-coagulants, and to diagnose some disease conditions. 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.

[October 8, 2003 - Recall Notice - FDA]
[September 30, 2003 - Product Recall Update for Health Professionals - Roche Diagnostics] PDF Format
[September 30, 2003 - Product Recall Update for Patients - Roche Diagnostics]