Events

Recall of Amplicor Detection Internal Control

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
    2004-07-12
  • 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-dmdiv-amplicor-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 the lots from the market. E13115 (version 31.07.05) of the in vitro diagnostic medical device called Amplicor Detection Internal Control - reference 207 633 06. E13307 (March 30, 2009) of the in vitro diagnostic medical device called Amplicor Mycobacterium tuberculosis detection (MTB) - reference 207 574 62. E11231 (version 30.09.04) of the in vitro diagnostic medical device called Amplicor HIV-1 Monitor v1.5 - reference 211 177 5. following the demonstration of the potential appearance of a blue precipitate during use of the conjugate Peroxidase-Avidin (AV-HRP) / lot E09659 contained in these batches .. The results returned with these lots are considered correct and valid. However, this precipitate can, in rare cases, increase the background noise in the Amplicor MTB device and result in lower positive results; the weakly positive results should be reviewed and reinterpreted according to the clinical data (according to the instructions). These devices use a molecular biology technique (PCR: Polymerase Chain Reaction) for the qualitative or quantitative research of specific nucleic acids. .. Amplicor Detection Internal Control is used with the manual Amplicor MTB Detection Kit for the detection of Mycobacterium tuberculosis. Amplicor HIV-1 Monitor v1.5 is a manual kit for the determination of HIV-1 RNA, used in the treatment of patients infected with HIV-1, known.

Device

Amplicor Detection Internal Control
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics