Events

Recall of VITROS ECI IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG REAGENT PACK

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
    117017
  • Event Risk Class
    II
  • Event Initiated Date
    2001-01-29
  • 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
    Possible incorrect placement of reagent bottles within the reagent pack and could result in calibration failures qc failures and/or biased sample results.

Device

VITROS ECI IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG REAGENT PACK
  • Model / Serial
    Model Catalog: 176 4877 (Lot serial: 144); Model Catalog: 835 6636 (Lot serial: 134)
  • Product Description
    VITROS IMMUNODIAGNOSTIC TOTAL B-HCG RE
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS