Events

Alerte De Sécurité sur Trepanostika TP recombinant

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
    2013-03-08
  • Date de publication de l'événement
    2013-03-08
  • 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_20130308.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 trepanostika tp recombinant medical device manufacturer, biomerieux, inc., has initiated a medical device field safety correction action concerning trepanostika tp recombinant with reference no.: 285034 and 285035. the affected lot numbers are d33ga, d33ha, d33ka, d33kb, d33kc, d33ma, d33n. following customer complaints on negative control out of range, biomerieux investigation has confirmed an issue with some lots of trepanostika tp recombinant and that the problem is due to the aluminum bag that contains the microelisa strip plates. the impacted strips may contain bad aluminum bags, or a mixture of good and bag aluminum bags. as a result, customers may either experience false results or negative control out of range. the investigation also determined that the 2 lots d33ma and d33na also show a reduced sensitivity which may lead to obtain false nonreactive results. the risk is considered as critical because false nonreactive results could lead to a non-reversible injury or illness to an individual or patient that requires immediate and/or major professional medical intervention. the manufacturer advises users stop using and discard the affected product that they may have in stock. also, the manufacturer advises users that for samples previously tested with the lots d33ka, d33kb, d33kc retest the samples having results with a ratio between 0.7 and 1.3. and for samples previously tested with the lots d33ma and d33na retest all the nonreactive samples. according to the local supplier, 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 8 march 2013.

Device

Trepanostika TP recombinant
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BioMerieux Trepanostika TP recombinant
  • Manufacturer
    BioMerieux

Manufacturer

BioMerieux