Events

Alerte De Sécurité sur Test Cells for Red Cell Antibody Screening

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

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
    2017-02-14
  • Date de publication de l'événement
    2017-02-14
  • 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_20170214.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: diamed test cells for red cell antibody screening medical device manufacturer, diamed, has issued a field safety notice concerning its test cells for red cell antibody screening. the product names (catalogue numbers) of the affected devices are as below: id-dia (diego) positive (004134); id-diacell sf (003640); id-diacell pool (003630 / 003631); id-diacell abo/i-ii (003610); id-diacell abo/i-ii-iii (003618); id-diascreen i-ii-iii-iv-vp-vip (004316); id-diacell i-ii (003613); id-diapanel (004114); id-diacell i-ii-iii (004310); id-diascreen i-ii-iii-iv (004311); id-diacell i-ii-iii asia (003614); id-diascreen prophylax (004330); id-diapanel plus 6 (004414); id-diacell i-ii (003613vj); id-diapanel (1-11) (004114vj ); id-dia positiv (004134vj); id-diacell i-ii-iii (004310vj) the manufacturer has identified unexpected reactions primarily on eluates and qc samples but also with some patient samples when using the above mentioned products. this phenomenon is observed randomly between batches, and also within single batches. according to the manufacturer, a risk assessment has been done, and the conclusion is that this unexpected result requires further confirmation testing before a final transfusion decision is made. negative results can be reliably accepted as negative. the manufacturer advises affected users of the following:- in case of doubtful reactions, re-test with a new kit. if the results remain in doubt, send the sample to a reference laboratory and if an urgent transfusion is required, perform a crossmatch. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 february 2017.

Device

Test Cells for Red Cell Antibody Screening
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: DiaMed Test Cells for Red Cell Antibody Screening
  • Manufacturer
    DiaMed

Manufacturer

DiaMed