Recall of Bio-Rad TPHA 200 and Bio-Rad TPHA 500 Reagents Trinity Biotech

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 Bio-Rad.

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
  • Event ID
    R1611799
  • Date
    2016-11-03
  • Event Country
  • Event Source
    ANSM
  • Event Source URL
  • 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
    The ANSM has been informed of the implementation of a product withdrawal carried out by the company BIO-RAD. The users concerned have received the attached mail, (03/11/2016) (199 KB) completed by ANSM information / recommendation. This safety action is registered with the ANSM under the number R1611799. Read too. Bio-Rad TPHA 200 and Bio-Rad TPHA 500 Reagents - (16/11/2016) Trinity Biotech - Safety Information

Device

  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer

Manufacturer