Events

Safety Alert for ACL TOP Family Coagulation Systems

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Werfen Group.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-07-25
  • Event Date Posted
    2013-07-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130725a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: werfen acl top family coagulation systems 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.

Device

ACL TOP Family Coagulation Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Werfen ACL TOP Family Coagulation Systems
  • Manufacturer
    Werfen Group

Manufacturer

Werfen Group