Events

Recall of i-STAT

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 N/A.

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
    1999-09-28
  • 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-de-reactifs-denommes-i-stat
  • 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 lots . M99092, M99103, M99106, M99118B and M99132 of the reagent called i-STAT EG6 + (Ref HPM3602A). K99091, K99105, K99106 and P99159 of the reagent called i-STAT G3 + (Ref HPM3603A). M99085 and M99086 of the reagent called i-STAT EG7 + (Ref HPM3601A). are withdrawn from the market due to early deterioration of the PO2 sensor system leading to the absence of PO2 results or excessively high PO2 results.

Device

i-STAT
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    LAANSM