Roche Diagnostics Recalls Blood Clotting Time Device

Basel, Switzerland-based Roche Diagnostics has notified the FDA that it has recalled all of the CoaguChek PT test strips currently on the market, due to a potential for a test strip defect that may cause falsely elevated test results.

As of October 19, no deaths, illnesses or injuries have been reported because of this device, but there has been one confirmed incident and Roche’s internal investigation suggests that a small percentage of strips may be affected.

The company has identified the root cause and is instituting corrective action.

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.