Events

Alerta De Seguridad para Biotestcell I8, Biotestcell I11 and Biotestcell I11E

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

¿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
    2014-06-20
  • Fecha de publicación del evento
    2014-06-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140620a.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: bio-rad biotestcell i8, biotestcell i11 and biotestcell i11e medical device manufacturer, bio-rad, has issued a field safety notice (fsn) concerning biotestcell i8 (code no. 816 020), biotestcell i11 (code no. 816 021) and biotestcell i11e (code no. 816 051). the affected lot number is 2422011-00. due to subsequent exchange of one donor cell in the cell panel of the products mentioned above, an incorrect version of the worksheet was used for packaging. this worksheet contains incorrect information for cell i7. with this incorrect worksheet an identification of anti-jkb, -s and -s antibodies is not possible. misinterpretations do not occur. using the affected reagents as control reagent will lead to a discrepant result misleadingly indicating a problem with the tested reagent (e.G. seraclone anti-jkb, anti-s, anti-s). the manufacturer advises users not to use worksheets included in the packages of the lots mentioned above. a fsn with corrected worksheets containing correct donor information for cell i7 was issued to alert users. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 20 jun 2014.

Device

Biotestcell I8, Biotestcell I11 and Biotestcell I11E
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Bio-Rad Biotestcell I8, Biotestcell I11 and Biotestcell I11E
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad