Field Safety Notice: Accriva Diagnostics - ProTime InRhythm PT Test Cuvettes

vrijdag 12 februari 2016 15:00

During a surveillance testing program, Accriva has determined that four (4) 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 labeled shelf-life and in the case of room-temperature storage for may lead to erroneous results or QC test failures.