It has come to our attention that the medical device manufacturer, Werfen Group, Instrumentation Laboratory has initiated a medical device field safety corrective action concerning ACL TOP Family Coagulation Systems. The affected models are ACL TOP, ACL TOP CTS, ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS and ACL TOP 300 CTS.
It has come to our attention that the medical device manufacturer, Werfen Group, Instrumentation Laboratory has initiated a medical device field safety corrective action concerning ACL TOP Family Coagulation Systems. The affected models are ACL TOP, ACL TOP CTS, ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS and ACL TOP 300 CTS.
The extent of the shortened clotting times varies from instrument to instrument and is not reproducible on all instruments. In certain instances, this issue has manifested itself as a downward shift in APTT clotting times of greater than 10 seconds.
The manufacturer is working on a software mitigation to address this issue. Until available, the manufacturer advises users use the workaround described in the field safety notice.
According to the local supplier, the affected products have been distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 July 2013