Events

Alerte De Sécurité sur BD ProbeTec Chlamydia trachomatis (CT) Qx Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx 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.

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
    2014-11-14
  • Date de publication de l'événement
    2014-11-14
  • 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_20141114a.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 probetec chlamydia trachomatis (ct) qx assay and the bd probetec neisseria gonorrhoeae (gc) qx assay medical device manufacturer, bd, has issued a field correction action concerning the bd probetec chlamydia trachomatis (ct) qx assay with catalogue number 442959 and the bd probetec neisseria gonorrhoeae (gc) qx assay with catalogue number 442842. the manufacturer has learned that some customers performing the bd probetec chlamydia trachomatis (ct) qx assay and the bd probetec neisseria gonorrhoeae (gc) qx assay with the viper lt instrument are experiencing a higher than expected rate of positive test results (i.E., increased prevalence). this observation is limited to a subset of test results obtained from specimens yielding “max rfu” values in the approximate range of 125 to 250. this includes occasionally obtaining positive results for the assay negative control. based on internal investigations to date, the manufacturer has confirmed that this change in test performance is attributable to an increase in false positive results. the anomaly only impacts ct/gc assay results on the viper lt. the manufacturer will provide affected users with alternative testing methods until the issue of false positive results is addressed. the manufacturer’s representatives will contact users directly to determine which methods/options would be the most viable to satisfy their testing needs. the interim solutions include testing on an alternate platform (viper xtr, probetec, or a competitor’s instrument) or sending the ct/gc testing out to alternate laboratories. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 november 2014.

Device

BD ProbeTec Chlamydia trachomatis (CT) Qx Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BD ProbeTec Chlamydia trachomatis (CT) Qx Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay
  • Manufacturer
    BD

Manufacturer

BD