Medicines & Healthcare products Regulatory Agency (MHRA) has issued a medical device safety alert concerning PROTIME InRhythm System PT Test Cuvettes [Lot number: K5PTD402-P1, K5PTD403-P2, K5PTD404-P3, K5PTD405-P4], manufactured by Accriva Diagnostics.
During its surveillance testing programme, the manufacturer has determined that the above four lots of the InRhythm PT Test Cuvettes are exhibiting accelerated degradation during both refrigerated and room-temperature storage conditions. This degradation indicates the product will not meet claimed performance for its full labelled shelf-life and in the case of room-temperature storage may lead to erroneous results or QC test failures.
According to the manufacturer, no adverse events have been reported due to this issue.
Product recall is ongoing.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 February 2016