International Medical Devices Database

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
2004-08-11
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-dmdiv-bactec-mgit-960-de-par-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
Becton Dickinson withdraws from the market. lot 4028645 (version 03.06.05) of the in vitro diagnostic medical device called BD BACTEC ™ MGIT ™ 960 SIRE Kit - reference 245123. batch 4076878 (version 23.06.05) of the in vitro diagnostic medical device known as the BD BACTEC ™ MGIT ™ 960 INH Kit 0.4 - reference 245126. batch 4076881 (version 23.06.05) of the in vitro diagnostic medical device called BD BACTEC ™ MGIT ™ 960 EMB 7.5 kit - reference 245127. following evidence of fungal / mold contamination of the BD BACTEC ™ MGIT ™ 960 SIRE / lot 3351099 supplement included in the above listed kits; this contamination can lead either to invalid results (positive growth control before 4 days), or, potentially, to a false interpretation of resistance to the anti-TB drugs tested. These devices are used for the rapid detection of the sensitivity of Mycobacterium tuberculosis to antimycobacterial agents. (streptomycin, isoniazid, rifampicin, ethambutol).

Device

BD BACTEC ™ MGIT ™ 960 SIRE Kit

Model / Serial
Product Description
in-vitro_medical_device
Manufacturer
BECTON DICKINSON

Manufacturer

BECTON DICKINSON

Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
LAANSM

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Recall of BD BACTEC ™ MGIT ™ 960 SIRE Kit

What is this?

Device

BD BACTEC ™ MGIT ™ 960 SIRE Kit

Manufacturer

BECTON DICKINSON