Events

Recall of Ortho CQI 7;Ortho CQI 9

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France 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
  • Date
    2003-12-03
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-d-un-lot-des-dmdiv-ortho-cqi-7-et-ortho-cqi-9
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    Ortho Clinical Diagnostics withdraws batch 391 (per 23.12.03) from the market of in vitro diagnostic medical devices called Ortho CQI 7 - reference 707787 and Ortho CQI 9 - reference 707789, following the expression - contrary to the antigenic profile reported - c antigen (RH4) by A2. This non-conformity invalidates the analyzes. This device is a panel of red blood cells and human sera used as internal quality controls ABO-D-Rh.K-RAI

Device

Ortho CQI 7;Ortho CQI 9

Manufacturer

ORTHO CLINICAL DIAGNOSTICS