Roche Recalls CoaguChek PT Test Strips
Roche Diagnostics is recalling all CoaguChek PT test strips currently in the market because of a potential for a test strip defect that may cause falsely elevated test results. These products are used to determine blood clotting time of patients taking anti-coagulants. According to Roche the potential for a test strip defect occurs when insufficient active ingredient (thromboplastin) is applied to the test strip. This can result in an incorrect dose of anti-coagulant or unnecessary corrective measures to reduce the effect of circulating anti-coagulants. Both incorrect treatment choices could put patients at risk for blood clots.
Roche Diagnostics is notifying all health care professionals who use the CoaguChek PT test strip to use two strips with different lot numbers on each patient to reduce the risk of bias. If health care professionals require another lot to enable duplicate testing, they are encouraged to call their medical supply distributor.
October 19, 2006 Related topics: Product Recalls