Events

Safety Alert for ortho biovue system cassettes

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
    2013-07-09
  • Event Date Posted
    2013-07-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130709.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 diagnosticsortho biovue system cassettes the medicines and healthcare products regulatory agency(mhra), united kingdom posted a field safety notice concerningortho biovue system cassettes, manufactured by ortho clinical diagnostics. ortho clinical diagnostics has identified isolated occurrences of improperly positioned cassette labels for certain products.An investigation confirmed that the cause of the issue occurred on one of our three manufacturing lines following a particular sequence of events.The occurrence rate of the issue is very low. the use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection results. there is no risk associated with the use of an affected single-reagent cassette since all wells contain the same reagent. the manufacturer advises users to inspect all cassettes from the potentially affected lots remaining in facility prior to use, by referring to the ortho biovue system cassette inspection procedure for visual detailed instructions; and do not use cassettes with an incorrectly positioned label and discard the affected cassette in accordance with local regulations. according to the local supplier, the affected products were distributed in hong kong. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con287036 if you are in possession of the product, please contact your supplier for necessary actions. posted on 9 july 2013.

Device

ortho biovue system cassettes
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ortho Clinical DiagnosticsORTHO BioVue System Cassettes
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics