Events

Alerte De Sécurité sur BD MAX MRSA Assay

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par BD Diagnostic Systems.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-08-01
  • Date de publication de l'événement
    2014-08-01
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140801b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: bd max mrsa assay medical device manufacturer, bd diagnostic systems, has issued a medical device safety alert concerning its bd max mrsa assay [catalogue no.: 442953; unit: 24 each; lot no.: all lots with an expiration date of 2014-01-21 or later]. according to the manufacturer, their investigation of incorrect results related to the college of american pathologists (cap) surveys mrs5-a 2014 and mrs5-b 2014 using the bd-max mrsa assay confirmed that one of the samples for each of the surveys yielded some false positive results. initial analytical testing has demonstrated previously unobserved cross-reactivity due to non-specific binding with certain methicillin-sensitive staphylococcus aureus (mssa) strains, primarily when these organisms are present at high loads (> 1 x 106 cfu/swab). based on the manufacturer’s assessment of the likelihood of a false positive result, as well as documented performance at customer sites, the assay continues to meet clinical performance claims. while there is the potential for a false positive result for specimens from patients who are positive for certain strains of mssa when present at high loads, the manufacturer believes that such an occurrence is unlikely and overall clinical performance would not be affected. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 01 aug 2014.

Device

BD MAX MRSA Assay
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BD MAX MRSA Assay
  • Manufacturer
    BD Diagnostic Systems

Manufacturer

BD Diagnostic Systems