Events

Recall of VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CA125II REAGENT PACK - 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
    123147
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-08
  • 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) has received customer complaints regarding a positive shift in patient results when using vitros immunodiagnostic products ca 125 ii reagent packs lots 1260 and above when compared to lot 1240. customers are being informed regarding a shift in results that may be observed when performing patient sample correlation tests between vitros ca 125 ii calibrators and reagent packs lots 1220 1230 1240 and/or 1250 compared to lots 1260 and above. internal testing has determined that the signal for all levels of affected lots of vitros ca 125 ii calibrator increased over the shelf life of the product resulting in negatively biased patient and quality control results. testing has confirmed that this issue is isolated only to lots 1220 1230 1240 and 1250.

Device

VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CA125II REAGENT PACK - CALIBRATOR
  • Model / Serial
    Model Catalog: 6800034 (Lot serial: 1250); Model Catalog: 6800034 (Lot serial: 1220); Model Catalog: 6800034 (Lot serial: 1230); Model Catalog: 6800034 (Lot serial: 1240)
  • Product Description
    VITROS Immunodiagnostic Products CA 125 II Calibrator
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS