Events

Alerte De Sécurité sur Corporation Citrate Activated Partial Thromboplastin Time (APTT) 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 International Technidyne Corporation.

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
    2014-01-03
  • Date de publication de l'événement
    2014-01-03
  • 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_20140103.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: international technidyne corporation citrate activated partial thromboplastin time (aptt) cuvettes the australia therapeutic goods administration (tga) posted a medical device safety alert concerning citrate activated partial thromboplastin time (aptt) cuvettes manufactured by international technidyne corporation.The affected lot numbers are e3jcc013-p1 and e3jcc014-p2 and the expiration date is may 2014. the manufacturer has determined that citrate aptt cuvettes from the lots listed above may recover higher than expected results in normal individuals. the manufacturer's investigation into the affected lots identified that when performing tests on non-heparinized e.G., normal blood samples, results may average higher than historic values. test results performed on patients receiving heparin therapy are not affected. the manufacturer has evaluated the risk to health using the affected device and has determined under a variety of clinical conditions, an erroneous increase in the citrated aptt baseline may contribute to serious injury. customers are requested to inspect their stock and quarantine all affected lots of the product, which will be arranged for recovery and replacement. customers are also advised to discuss with the laboratory director about the requirement for retesting of reported patient results. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01364-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 january 2014.

Device

Corporation Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: International Technidyne Corporation Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes
  • Manufacturer
    International Technidyne Corporation

Manufacturer

International Technidyne Corporation