Events

Recall of Stratus TestPak reagents;Stratus diluents DilPak

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 DADE BEHRING.

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
    2006-04-06
  • 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-des-reactifs-stratus-testpak-et-diluants-stratus-dilpak-dade-behring
  • 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 April 5, 2006, Dade Behring withdrew from the market 47 batches of Stratus TestPak reagents and Stratus DilPak diluents used on the Stratus CS system, a list of which is detailed in the enclosed mail (05/04/2006) (34 ko) .. In addition, 22 other lots are subject to a reduction in the shelf life to 2 months (see attached letter). These reagents and diluents are used for the quantitative determination of CKMB, troponin I, myoglobin, proBNP, D-dimer and beta hCG on the Stratus CS system. This measure follows the possibility that the aluminum film covering the reagents and diluents may obstruct the sampling tip thus causing insufficient reagent aspiration. The results obtained can then be falsely raised or lowered. The company has directly notified the recipients of the incriminated lots by means of the attached message validated (05/04/2006) (34 KB) by Afssaps. address to laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Stratus TestPak reagents;Stratus diluents DilPak
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM