Events

Safety Alert for VerifyNow IIb/IIIa 25-Test and 10-Test Kits

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

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
    2014-03-04
  • Event Date Posted
    2014-03-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140304.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: accumetrics verifynow iib/iiia 25-test and 10-test kits the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning verifynow iib/iiia 25-test and 10-test kits [product codes: 85011 and 85310; reference number: ivd14.014; capa 13-014] manufactured by accumetrics. during its surveillance, the manufacturer has determined that the affected verifynow iib/iiia test kit lots may result in the reporting of an erroneous low platelet aggregation unit (pau) result. corrective actions are being implemented to prevent these issues from affecting future lots of verifynow iib/iiia test kits. the manufacturer has not received any reports of adverse events for these issues. according to the manufacturer, a lower than actual or expected pau values may contribute to excess administration of iib/iiia anti-platelet agents, which has the potential to lead to an adverse event. typically, higher doses of anti-platelet agents are associated with higher risk of bleeding. the manufacturer advises all affected users to check their inventory to determine if they have any affected verifynow iib/iiia test kits. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con382708 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 march 2014.

Device

VerifyNow IIb/IIIa 25-Test and 10-Test Kits
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Accumetrics VerifyNow IIb/IIIa 25-Test and 10-Test Kits
  • Manufacturer
    Accumetrics

Manufacturer

Accumetrics