Events

Recall of FETALSCREEN II

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
    81990
  • Event Risk Class
    III
  • Event Initiated Date
    2012-02-06
  • 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
    Ocd received customer complaints for fetalscreen ii kit lot v116323 item z488 (exp: 10-jan-2012) pertaining to the positive control cell failing qc (less than 3 rosettes in 5 fields) or showing weakened reactivity. according to the alba bioscience product ifu if the total number of agglutinates or rosettes in 5 fields is 3 or more the test is positive.

Device

FETALSCREEN II
  • Model / Serial
    Model Catalog: Z488 (Lot serial: V116323)
  • Product Description
    FETALSCREEN II Fetal Maternal Hemorrhage Screening Test
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS