Events

Safety Alert for PROTIME InRhythm System PT Test Cuvettes

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

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
    2016-02-11
  • Event Date Posted
    2016-02-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160212b.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: protime inrhythm system pt test cuvettes medicines & healthcare products regulatory agency (mhra) has issued a medical device safety alert concerning protime inrhythm system pt test cuvettes [lot number: k5ptd402-p1, k5ptd403-p2, k5ptd404-p3, k5ptd405-p4], manufactured by accriva diagnostics. during its surveillance testing programme, the manufacturer has determined that the above four lots of the inrhythm pt test cuvettes are exhibiting accelerated degradation during both refrigerated and room-temperature storage conditions. this degradation indicates the product will not meet claimed performance for its full labelled shelf-life and in the case of room-temperature storage may lead to erroneous results or qc test failures. according to the manufacturer, no adverse events have been reported due to this issue. product recall is ongoing. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 february 2016.

Device

PROTIME InRhythm System PT Test Cuvettes
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: PROTIME InRhythm System PT Test Cuvettes
  • Manufacturer
    Accriva Diagnostics

Manufacturer

Accriva Diagnostics