Events

Safety Alert for vitros chemistry products specialty diluent and vitros chemistry products fs diluent pack 3

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
    2014-03-28
  • Event Date Posted
    2014-03-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140328a.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 chemistry products specialty diluent and vitros chemistry products fs diluent pack 3 medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its vitros chemistry products specialty diluent lot f3168 (product code 8559825) & vitros chemistry products fs diluent pack 3 lot 01-3266 (product code 6801754). the manufacturer confirmed reports of lower than expected c-reactive protein (crp) results when using the affected lots of vitros specialty diluent and vitros fs diluent pack 3 to dilute samples tested on vitros crp slides. when using the affected lots of diluent, results using vitros crp slides may be negatively biased by approximately 51% using a 3x dilution factor. the manufacturer advises affected users to take the following actions:- immediately discontinue using and discard all remaining inventory of vitros specialty diluent, lot f3168 and/or vitros fs diluent pack 3, lot 01-3266. review previously reported results using the affected lots. discuss any concerns regarding previously reported results with their laboratory medical director or with the requesting physician. according to the manufacturer, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 mar 2014.

Device

vitros chemistry products specialty diluent and vitros chemistry products fs diluent pack 3
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics