Events

Alerta De Seguridad para Test Cells for Red Cell Antibody Screening

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por DiaMed.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2017-02-14
  • Fecha de publicación del evento
    2017-02-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170214.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: DiaMed Test Cells for Red Cell Antibody Screening
  • Manufacturer
    DiaMed

Manufacturer

DiaMed