Events

Recall of IMMAGE BUFFER 1

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 BECKMAN COULTER.

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
    2002-10-14
  • 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-du-reactif-immage-buffer-1-reference-447650-de-la-societe-beckman-coulter
  • 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
    BECKMAN COULTER withdraws from the market batches T111211 (expiry date 30/11/03), T202122 (expiry date 29/02/04), T202211 (expiry date 29/02/04) and T204184 (expiry date 30/04/04) of the reagent called IMMAGE BUFFER 1 / reference 447650 following a drift of quality controls during the use thereof, this drift being due to the instability of one of the components used in the manufacture of this reagent .. This reagent is used for the determination of specific proteins (see list) on the IMMAGE automaton. List of proteins. A1M Alpha 1 microglobulin. AAG Orosomucoid or Alpha 1 glycoprotein acid. AATAlpha 1 antitrypsin. ALB Albumin. AMG Alpha 2 macroglobulin. APA Apolipoprotein A. APB Apolipoprotein. AT3 Antithrombin II. B2MX Beta 2 microglobulin. C3 Complement C. C4 Complement C. CER Ceruloplasmin. HPT Haptoglobin. IGA Immunoglobulin A (IGALC IGALC IgG immunoglobulin A low concentration IgG immunoglobulin G (IgG IgM immunoglobulin M (IgM IgMLC immunoglobulin M low concentration IGU immunoglobulin G urinair KAP light chains kapp LAM light chains lambda LPAX lipoprotein ( A. MA Microalbumin, PAB Prealbumin, PFB Properdine Factor, TRF Transferrin, TRU Urinary Transferrin

Device

IMMAGE BUFFER 1
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER