Events

Recall of TTC (Ten Tip Cassette). 10-well cassette)

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 CHIRON BLOOD TESTING.

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
    2001-07-13
  • 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-cassettes-de-10-embouts-ttc
  • 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
    On July 11, 2001, CHIRON BLOOD TESTING removed from the market batches 021087, 022087, 023079, 028092, 029081, 030068, 031099, 033084, 034064, 035062, 120081 of the in vitro diagnostic medical device known as TTC (Ten Tip Cassette). 10-well cassette), reference 104578, used with the Chiron TMA HIV-1 / HCV Assay reagent. This withdrawal is the result of a manufacturing defect (length of some tips below the required specifications) leading to invalid results.

Device

TTC (Ten Tip Cassette). 10-well cassette)

Manufacturer

CHIRON BLOOD TESTING
  • Source
    LAANSM