Events

Alerte De Sécurité sur SLIDEX Strepto Plus

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

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
    2015-10-28
  • Date de publication de l'événement
    2015-10-28
  • 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_20151028.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: biomerieux slidex strepto plus medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its slidex strepto plus [product number: 58811; lot number: 1501111348; expiration date: 08-jan-2016]. according to the manufacturer, a customer complaint investigation confirmed a stability issue associated with slidex strepto plus latex b reagent (lot# 1501111348) when exposed to thermal shock conditions either during transportation or storage. product exposed to thermal shock exhibited weak or no agglutination. as a result of weak or no agglutination to the latex b reagent, there is a potential for a false negative result with group b streptococcus colonies. product that was stored under normal conditions was determined to perform within specifications and produce proper agglutination. in order to determine whether the product is affected by this issue, affected users are instructed to perform the following steps: prior to each use with clinical samples, perform the quality control procedure referenced within the package insert using the positive controls. if the product produces a positive result with the positive controls, as described in the “readings and interpretation of results” section of the package insert, then utilize the product to process the clinical sample(s). if the product produces a negative result with the positive controls, as described in the “readings and interpretation of results” section of the package insert, then discontinue use of that kit of the product, dispose of the affected product. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 october 2015.

Device

SLIDEX Strepto Plus
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BioMerieux SLIDEX Strepto Plus
  • Manufacturer
    BioMerieux

Manufacturer

BioMerieux