Events

Recall of Elecsys Calset Folate I

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 Roche 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
    2004-04-06
  • 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-du-dmdiv-elecsys-calset-folate-i-de-par-roche-diagnostics
  • 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
    Roche Diagnostics withdraws lot 166937 (per 31.07.04) from the market for the in vitro diagnostic medical device called Elecsys Calset Folate I - reference 11820877, due to a lack of stability that can lead to an increase (up to 25%) values ​​of the results - patients and quality controls - and the obtaining of out-of-specification results for the quality controls (invalidation of the series of assays). This device makes it possible to perform the calibration necessary for the determination of folates in human serum, on Elecsys analyzers. The results of this assay should be compared with erythrocyte folate results, patient history data, clinical presentation and results of other biological analyzes.

Device

Elecsys Calset Folate I
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics