Events

Recall of QUELAB Chlamydia 2SP Collection and Transport Kit

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
    2004-06-29
  • 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-quelab-chlamydia-2sp-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
    The Roche Diagnostics company withdraws from the market batches 2111 (per.08.10.04) and 2211 (per.15.10.04) of the in vitro diagnostic medical device called QUELAB Chlamydia 2SP Collection and Transport Kit - reference 207 648 09122, following the highlighting a leak at the plug of some tubes. to note :. the defect can not be detected before use of the tubes because they are stored in the frozen state and the 2SP medium contains 3 antibiotics. the results obtained for the samples from tubes which do not show any leak or are not contaminated by a defective tube are not to be questioned. This device is intended for the collection and transport of "Chlamydia" biological samples.

Device

QUELAB Chlamydia 2SP Collection and Transport Kit
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics