Events

Recall of BBL Crystal Rapid Stool / Enteric ID 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 BECTON DICKINSON.

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
    2002-06-04
  • 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-d-un-lot-du-reactif-bbl-crystal-rapid-stool-enteric-id-kit-de-becton-dickinson
  • 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 Becton Dickinson withdraws from the market lot 1225152 (per.01.08.02) of the in vitro diagnostic medical device called BBL Crystal Rapid Stool / Enteric ID Kit - reference 245050, following the possibility of obtaining false positive results for patients. tests carried out with the substrate IPH (indoxyl phosphate), including with the quality control strain Pseudomonas aeruginosa ATCC 27853 (expected to be negative IPH). This test allows the identification of Gram-negative Enterobacteriaceae (Enterobacterioceae and Vibrionaceae) by a miniaturized method employing modified chromogenic and conventional substrates.

Device

BBL Crystal Rapid Stool / Enteric ID Kit
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON