Events

Safety Alert for vitros chemistry products dat performance verifiers

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
    2017-09-20
  • Event Date Posted
    2017-09-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170920.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 dat performance verifiers medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its vitros chemistry products dat performance verifiers [product code (lot number): 6802327 (h5616); 6802328 (j5617); 6802329 (k5618); 6802330 (l5619); 6802331 (m5620)]. this notification provides information regarding lower than expected quality control (qc) results obtained for vitros benz reagent using the specific lots of vitros dat performance verifier listed above. the manufacturer performed an investigation and determined that qc results for benz (only) were lower than expected when using the affected lots. data confirmed that the concentration of lormetazepam (benz) in the affected lots of vitros dat pvs has shown a decrease over time. there are reduced levels of lormetazepam when the controls were tested on a confirmatory method (i.E., gas chromatography/mass spectrometry). no other assays in the vitros dat performance verifiers are affected by this issue. if the issue occurs, qc results for benz may be at or below ortho’s range of means as defined in the assay sheets. this issue may lead to an inability to verify calibration or cause failures in daily qc results. according to the manufacturer, if the qc results using vitros dat performance verifiers are within the established ranges for each assay, it is acceptable to use the affected lots until a replacement order arrives. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 september 2017.

Device

vitros chemistry products dat performance verifiers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifiers
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics