Roche Diagnostics has issued an important recall of all CoaguChek® PT test strips due to a potential for a test strip defect that may cause falsely elevated test results. CoaguChek PT test strips are used by patients and professionals to determine blood clotting time of patients taking anti-coagulants, also known as blood thinners. Blood thinners are used to treat patients with a potential for blood clots. Incorrect results may have serious or life threatening consequences as patients may be improperly treated.
Roche Diagnostics determined an insufficient amount of active ingredient (thromboplastin) applied to the test strip may possibly cause falsely elevated results. As a result of the unpredictable positive bias, patient test results may be falsely elevated. 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 home users of the CoaguChek PT test strip to immediately discontinue use of the product.
