Events

Recall of PHENOPLAC RH-KELL device

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 DIAGAST.

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
    2003-02-11
  • 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-dispositifs-phenoplac-de-la-societe-diagast
  • 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 company DIAGAST asks the holders of the lots. 108000 (per.02.03) to 114000 (per.11.03) of the in vitro diagnostic medical device called PHENOPLAC TOTAL - ref. 79713/79724. 108000 (per.02.03) to 111000 (per.09.03) of the PHENOPLAC RH-KELL device - ref. 79710/79725. 106000 (per.02.03) and 107000 (per.06.03) of the device PHENOPLAC STANDARD - ref.79712 / 79725. 103000 (per.07.03) of the PHENOPLAC 16 RH-KELL device - ref. 79716. not to use them any more and to destroy them as soon as you receive lots 115000 (per.12.03) of the device PHENOPLAC TOTAL - ref. 79724 and 112000 (per.12.03) of the device PHENOPLAC RH-KELL - ref.79730 .. This measurement is consecutive to a modification of the packaging of each microplate of the boxes guaranteeing the reactivity of the anti-e (RH5) antibody / MS16 clones + MS63 present in these plates and consequently, leading to the suppression of the systematic control, with another reagent, results "e" (RH5) negative; this measure avoids any confusion of use related to the coexistence of two techniques for the same reference.

Device

PHENOPLAC RH-KELL device
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DIAGAST

Manufacturer

DIAGAST