Events

Recall of AIA PACK ucPA

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 TOSOH BIOSCIENCE.

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
    2003-11-26
  • 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-aia-pack-ucpa-de-par-tosoh-bioscience
  • 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
    TOSOH BIOSCIENCE withdraws from the market lot H911305 / T (per 30.03.04) of the in vitro diagnostic medical device called AIA PACK ucPA - reference E06-01-5202TB, following the highlighting - during quality checks internals - possibility of drift of the ucPA values ​​of the multi-control AIA-Pack / levels 1, 2, 3; this drift results in an increase of the values ​​beyond the fixed limits. This device allows the determination of the uncomplexed fraction of prostate specific antigen (ucPA) in human serum, on TOSOH AIA SYSTEM analyzers. This assay, in addition to the total PSA assay, may help to discriminate between benign prostatic hypertrophy and prostate cancer.

Device

AIA PACK ucPA
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    TOSOH BIOSCIENCE

Manufacturer

TOSOH BIOSCIENCE
  • Source
    LAANSM