Events

Alerte De Sécurité sur BD PrepStain Slide Processors

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
    2013-08-16
  • Date de publication de l'événement
    2013-08-16
  • 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_20130816a.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 prepstain slide processors medical device manufacturer, bd has issued a medical device safety alert concerning the following prepstain slide processors: prepstain ag with catalogue numbers 05cr00021, 05cr00021r, 05cr00022, 05cr00022r, 05cr00023 and 05cr00023r prepstain tecan us-i with catalogue numbers 799-13000-00 and 799-13000-00r prepstain tecan us-ii with catalogue numbers 799-14000-00 (490100) and 799-14000-00r (490407) based on a report from the field, bd has determined that a prepstain slide processor rack setting was incorrectly entered on one prepstain system during a routine preventive maintenance visit by a bd field service representative. this incorrect rack setting has the potential to cause a sample mismatch for specimen test results. to determine whether a device is impacted by a similar error, bd advises users to observe a full 48 slide run (approximately 45 minutes) that will verify the appropriate gyn and non-gyn prepstain system operations during sample transfer. the rack setting inspection procedure is described in the safety notice. if the instrument is not impacted by this issue, no further action will be necessary. if the instrument is impacted, a bd service representative will schedule an on-site visit to adjust the rack settings. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 august 2013.

Device

BD PrepStain Slide Processors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BD PrepStain Slide Processors
  • Manufacturer
    BD

Manufacturer

BD