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U.S. Department of Health and Human Services

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Roche Diagnostics CoaguChek PT Test Strips

Audience: Consumers, Physicians and Hospital risk managers and laboratory managers

[Posted 10/20/2006] Roche Diagnostics and FDA informed consumers and healthcare professionals of the recall of CoaguChek PT test strips used to determine blood clotting time of patients taking anti-coagulant medication to prevent blood clots. The recall was due to the potential for a test strip defect that may cause falsely elevated test results. This may result in an incorrect dose of anti-coagulant medication or unnecessary corrective measures being taken to reduce the effect of circulating anti-coagulants. Healthcare professionals who use CoaguChek PT test strips should institute 'duplicate testing', or use two strips with different lot numbers, on each patient to reduce the risk of bias. Home users of CoaguChek PT test strip should immediately discontinue use of the product and contact their healthcare provider.

[October 20, 2006 - Press Release - Roche Diagnostics]