Events

Recall of Imx glycated hemoglobin calibrators

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 ABBOTT Diagnostic.

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
    2001-03-05
  • 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-denomme-calibrateurs-hemoglobine-glyquee-imx
  • 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
    Removal of batches 68577M200 (per 24.04.01) and 68577M201 (per 24.01.01) from the reagent called Imx glycated hemoglobin calibrators - ref. 1A86-01 of the company ABBOTT Diagnostic are withdrawn from the market because of the risk of obtaining values ​​lower than the specifications for the low control. To note: no impact for the patient, in fact, the dosages are invalidated by the out-of-specification values.

Device

Imx glycated hemoglobin calibrators
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ABBOTT Diagnostic

Manufacturer

ABBOTT Diagnostic
  • Source
    LAANSM