Events

Safety Alert for Access BR Monitor

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

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
    2017-04-18
  • Event Date Posted
    2017-04-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170418a.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: beckman coulter access br monitor medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its access br monitor for use with the access family of immunoassay systems [reference 387620; all non-expired lots and future lots]. following biases observed in the results of the french national quality controls, the manufacturer has been informed that a study completed by the french competent authority agence nationale de sécurité du medicament et des produits de santé (ansm) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu). according to the manufacturer, the ansm’s preliminary study demonstrated that 10 out of 27 patients diagnosed with cancer in non-remission had a result below the access br monitor url. the manufacturer is evaluating the access br monitor cutoff. the conclusions of this evaluation are planned by the third quarter of 2017. affected users are advised to ensure their laboratory staff and clinicians are aware of the limitations of the access br monitor assay found in the ifu. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 april 2017.

Device

Access BR Monitor
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter Access BR Monitor
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter