Medical device manufacturer, Ortho Clinical Diagnostics, has issued a medical device safety alert concerning its Calibration Data Module (CDM PROM) [Affected lot: 0168 Catalogue number: 1999077]. A CDM PROM is an electronic device that contains data required to perform various tests on the VITROS DT60/DT60 II Chemistry Systems.
According to the manufacturer, this product correction notification has been initiated due to an inability to calibrate or use VITROS CRSC DT Slides, GEN 82 when using CDM PROM 0168. Calibration Data Module (CDM PROM) 0168 contains data that allows the use of new lots of VITROS DT Slides and VITROS DT Calibrator Kits on VITROS DT60/DT60 II Chemistry Systems. This CDM PROM was sent to all customers beginning in October 2013. The manufacturer has received complaints for the inability to calibrate or subsequently use VITROS CRSC DT Slides, GEN 82 after the installation of CDM PROM 0168.
According to the local supplier, the affected products were NOT distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 07 February 2014