Events

Recall of VITROS ECI IMMUNODIAGNOSTIC SYSTEM ANTI-HBS REAGENT/CALIBRATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58423
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Ortho clinical diagnostics (ocd) is notifying customers of the potential for non-reproducible and unexpected positive results for negative anti-hbs reagent packs lots 2280 2290 2302 and 2310. these lots were distributed beginning in november 2012 and all lots have now expired. ocd internal data indicates that the rate of occurrence is variable the maximum observed rate of occurrence for the affected lots was 4 out of 104 negative anti-hbs patient samples which represents approximately 3.9% of negative samples tested. users are being advised to review all previously reported results between >12 and <30 miu/ml. a false positive result considers that a person is presumed to be immune to an hbv infection leaving the person susceptible to an hbv infection.

Device

VITROS ECI IMMUNODIAGNOSTIC SYSTEM ANTI-HBS REAGENT/CALIBRATOR
  • Model / Serial
    Model Catalog: 1787753 (Lot serial: 2310); Model Catalog: 1524693 (Lot serial: 2310); Model Catalog: 1787753 (Lot serial: 2302); Model Catalog: 1524693 (Lot serial: 2280); Model Catalog: 1787753 (Lot serial: 2290); Model Catalog: 1524693 (Lot serial: 2290); Model Catalog: 1787753 (Lot serial: 2280); Model Catalog: 1524693 (Lot serial: 2302)
  • Product Description
    VITROS Immunodiagnostic Products Anti-HBs Calibrator and Reagent Pack
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS