Events

Alerte De Sécurité sur BD Pharmingen, Horizon and Phosflow

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.

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
    2017-03-09
  • Date de publication de l'événement
    2017-03-09
  • 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_20170309a.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 pharmingen, horizon and phosflow medical device manufacturer, bd, has issued a medical device safety alert concerning its products: bd pharmingen [product format: alexa fluor 700, apc-cy 7, apc-h7, pe-cy 5], bd horizon [product format: apc-r700, buv661, bv605, bv650, bv711, bv786, pe-cf594] and bd phosflow [product format: alexa fluor 700]. the manufacturer has observed an increase in the number of complaints of low or no signal, or lot-to-lot variability in signal for single vial reagents with fluorophores. in some cases, users observed vial-to-vial variability in signal within the same lot. based on internal investigations, the manufacturer has identified specific lots of the above product formats, shipped between 16 may 2016 and 10 february 2017, that are being recalled. the manufacturer has launched a thorough investigation to identify root cause for the sporadic degradation of the reagents. at this time, all data suggest that a significant change in the lighting conditions at an alternate warehouse location is the primary contributor of the low to no signal in the product. based on the investigation, the current storage requirement on the product labeling, “store undiluted at 4°c and protected from prolonged exposure to light,” is sufficient to protect the product from degradation. according to the manufacturer, the potential degradation of product may result in a false identification of cell populations and/or aberrant staining patterns. the manufacturer advises users to take the following actions: either discard any remaining inventory and request a replacement or perform quality control using biological cells per their standard protocol on each vial of reagent just prior to use to confirm that the reagent is still performing as intended; and review any data that may have been generated from the affected product list. 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 9 march 2017.

Device

BD Pharmingen, Horizon and Phosflow
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BD Pharmingen, Horizon and Phosflow
  • Manufacturer
    BD

Manufacturer

BD