MHRA ISSUES MEDICAL DEVICE ALERT FOR DIAGNOSIS TEST

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert last week warning of increased risk of false negative results with the Clearview Simplify D-dimer test manufactured by Unipath.

The test is intended to aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis (DVT) and pulmonary embolism. Unipath initiated a recall and informed the MHRA after the original manufacturer reported a decrease in sensitivity in the product. For example, a negative result may be used to rule out DVT, and patients could be discharged without further investigation or treatment, according to the alert, which requested immediate action by healthcare personnel and medical staff using these devices.

The false negative results are possible on low-level D-dimer samples tested since Nov. 6, 2006, the company said. Unipath has recalled two lots of the product and is conducting an investigation into the root cause of the problem.