Events

Recall of UniCAP Total IgE Curve Controls;Pharmacia CAP System IgE FEIA Standards;Pharmacia CAP System IgE RIA Standards

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 PHARMACIA & UPJOHN.

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
    2000-09-22
  • 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-de-lots-des-reactifs-denommes-unicap-total-ige-unicap-total-ige-calibrators-unicap-total-ige-curve-controls-pharmacia-cap-system-ige-feia
  • 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
    The lot. AF91, AEET, AEES, ADVE, ADIS (per 30.06.2001); ACBR, ABUZ, AB57, AAGZ (per 30.04.2001); A9HD, A8SA, A80C, A70K (31.01.2001) of the reagent called UniCAP Total IgE - reference 10-9251-01. AEP8, ADLR (per 30.06.2001); AC7P, AB58, A9JG, A98Y (31.01.2001) of the reagent called UniCAP Total IgE Calibrators - reference 10-9252-01. AE30, ADJH (per 30.06.2001); ACBS, ABFL, AAYG (per 30.04.2001); AARP, AARN, A9HG, A838, A6PK (31.01.2001) of the reagent called UniCAP Total IgE Curve Controls - reference 10-9257-01. AAS3, A73X, A5VB, A5NI (31.01.2001) of the reagent called Pharmacia CAP System IgE FEIA Standards -reference 10-9394-01. AC2L, AAHX (30.06.2001) of the reagent called Pharmacia CAP System IgE RIA Standards - reference 10-9123-0. of PHARMACIA & UPJOHN are withdrawn from the market due to a lack of stability of the calibration solutions and controls used for the determination of total IgE.

Device

UniCAP Total IgE Curve Controls;Pharmacia CAP System IgE FEIA Standards;Pharmacia CAP System IgE ...
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    PHARMACIA & UPJOHN

Manufacturer

PHARMACIA & UPJOHN
  • Source
    LAANSM