Events

Safety Alert for HemosIL PT-Fibrinogen HS PLUS

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

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
    2014-12-02
  • Event Date Posted
    2014-12-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141202a.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: instrumentation laboratory hemosil pt-fibrinogen hs plus the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning hemosil pt-fibrinogen hs plus manufactured by instrumentation laboratory. according to the manufacturer, some vials of hemosil pt-fibrinogen hs plus exhibit a yellow/brownish colour after reconstitution instead of the typical white to off-white colour. these vials were observed to cause prolonged prothrombin (pt) clotting times. this issue is attributed to higher levels of residual moisture in some vials. corrective action has been implemented starting with lot n0640734 (jun2014) to prevent further occurrences of excess moisture in the vials. the manufacturer advises the affected users to: discard vials exhibiting yellow/ brownish colour after reconstitution; and run quality controls at least once every 8 hours in accordance with good laboratory practice and insert sheet instructions. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con477294 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 december 2014.

Device

HemosIL PT-Fibrinogen HS PLUS
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Instrumentation Laboratory HemosIL PT-Fibrinogen HS PLUS
  • Manufacturer
    Instrumentation Laboratory

Manufacturer

Instrumentation Laboratory