Events

Recall of True- Sign hCG reference V9900 (200 tests)

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 ServiBio.

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
    2005-09-12
  • 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-du-dmdiv-true-sign-hcg-servibio
  • 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 09 September 2005, the company ServiBio withdrew from the market batches 2005032301 (per 09/2006), 200506903 (per 12/2006) and 2005071001 (per 01/2007) of the in vitro diagnostic medical device called True- Sign hCG reference V9900 (200 tests) following the detection of false negative results. This device is a qualitative first-line test for the detection of hCG in serum and urine, for the biological diagnosis of pregnancy. The company has directly notified the recipients of the incriminated lots by means of the attached message ( 09/09/2005) (15 KB) validated by the Afssaps. This message is completed by a letter Afssaps (09/09/2005) (25 ko) on the modalities to follow for the patients whose hCG screening would have been found negative with the aforementioned lots. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

True- Sign hCG reference V9900 (200 tests)
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ServiBio

Manufacturer

ServiBio
  • Source
    LAANSM