Events

Recall of Reflotron GPT;Reflotron GOT

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
    2004-07-16
  • 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-dmdiv-reflotron-gpt-et-reflotron-got-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 from the market:. 237 172 31 (per 30.06.05) of the in vitro diagnostic medical device called Reflotron GPT - reference 10745138. 236 651 33 (per 31.08.05); 236 652 32 (per 30.06.05). 236 653 33 (per 30.09.05) of the in vitro diagnostic medical device called Reflotron GOT - reference 10745120. following some underestimated results. These devices allow the quantitative determination, using Reflotron® devices, of GPT (pyruvic glutamic transaminase or ALAT / alanine amino transferase) or GOT (glutamic transaminase). oxaloacetic acid or ASAT / aspartate amino transferase) in blood, serum or plasma. A note. Although there have been no deficiencies reported for some of these batches, Roche Diagnostics has decided to remove them because the same component is involved in their manufacture. the results of the GPT and GOT activities should always be interpreted taking into account the history, the clinical examination and the results of other biological analyzes.

Device

Reflotron GPT;Reflotron GOT
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics