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