Events

Safety Alert for vitros 25-oh vitamin d total calibrators

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
    2014-01-29
  • Event Date Posted
    2014-01-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140129.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 vitros 25-oh vitamin d total calibrators medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its vitros 25-oh vitamin d total calibrators [product code: 6842893; lot numbers: 0091 through 0235]. the manufacturer has found that the vitros immunodiagnostic product 25-oh vitamin d total calibrators, lots 0091 through 0235, used with vitros immunodiagnostic products 25-oh vitamin d total reagent packs, may generate negatively biased results the manufacturer advises all affected users to immediately discard all current lots of vitros immunodiagnostic product 25-oh vitamin d total calibrators and reagent packs (lots 0200, 0210, 0220, 0230 and 0235). affected users are also instructed to review previously reported results generated using vitros immunodiagnostic product 25-oh vitamin d total calibrators, lots 0091 through 0235. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 january 2014.

Device

vitros 25-oh vitamin d total calibrators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS 25-OH Vitamin D Total Calibrators
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics