Events

Safety Alert for Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Ortho Clinical 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
    2014-07-28
  • Event Date Posted
    2014-07-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140728.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: ortho clinical diagnostics blood grouping reagent mts a/b/d monoclonal and reverse grouping card medical device safety alert: ortho clinical diagnostics blood grouping reagent mts a/b/d monoclonal and reverse grouping card the manufacturer observed an increased number of complaints related to false positive and/or reactions containing haze in the anti-a and buffered gel micro-tubes used for reverse abo typing in the mts a/b/d monoclonal and reverse grouping card lots listed above. investigation by the manufacturer determined that the false positive reactions were due to broken gel beads in the micro-tubes of the mts cards. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following health canada website: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/40629r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 july 2014.

Device

Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ortho Clinical Diagnostics Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics