Events

Recall Or Safety Alert for Cartridge (test) for VerifyNow IIb / IIIa inhibitors to the optical turbidimetric system for the quantitative assessment of platelet-induced aggregation of VerifyNow

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Accumetrics Inc., UNITED STATES OF AMERICA.

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
    Recall / Safety alert
  • Event Number
    ИМ-7.99208
  • Date
    2014-11-03
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 recall data from the U.S. and Belarus.
  • Extra notes in the data
  • Reason
    Accumetrics withdraws the verifynow iib / iiia test (serial numbers: wc0182b, wc0182c, wc0182a, a, a0101d, wc0182e, wc0182f, wc0182g, wc0180c, wc0180e, wc0180f, wc0181a, wc0181c, wc0181d, wc0181f, wc0180a, wc0180f, wc0181a, wc0181c, wc0181c, wc0181f, wc0180a, wc0180f, wc0181a, wc0181e, wc0181c wc0181g, wc0181h, wc0181j, wc0181k) due to the fact that this may lead to erroneous results with low levels of platelet aggregation (pau). accumetrics sent letters with information about what actions need to be taken in this situation.

Device

Cartridge (test) for VerifyNow IIb / IIIa inhibitors to the optical turbidimetric system for the ...

Manufacturer

Accumetrics Inc., UNITED STATES OF AMERICA