Events

Alerte De Sécurité sur PROTIME InRhythm System PT Test Cuvettes

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

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
    2016-02-11
  • Date de publication de l'événement
    2016-02-11
  • 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_20160212b.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: protime inrhythm system pt test cuvettes medicines & healthcare products regulatory agency (mhra) has issued a medical device safety alert concerning protime inrhythm system pt test cuvettes [lot number: k5ptd402-p1, k5ptd403-p2, k5ptd404-p3, k5ptd405-p4], manufactured by accriva diagnostics. during its surveillance testing programme, the manufacturer has determined that the above four lots of the inrhythm pt test cuvettes are exhibiting accelerated degradation during both refrigerated and room-temperature storage conditions. this degradation indicates the product will not meet claimed performance for its full labelled shelf-life and in the case of room-temperature storage may lead to erroneous results or qc test failures. according to the manufacturer, no adverse events have been reported due to this issue. product recall is ongoing. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 february 2016.

Device

PROTIME InRhythm System PT Test Cuvettes
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: PROTIME InRhythm System PT Test Cuvettes
  • Manufacturer
    Accriva Diagnostics

Manufacturer

Accriva Diagnostics