Alerta De Seguridad para COULTER Ac•T Pak Reagent Kit, COULTER Ac•T Tainer Reagent Kit, COULTER Diff Ac•T Pak and COULTER Diff Ac•T Tainer

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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: beckman coulter coulter ac•t pak reagent kit, coulter ac•t tainer reagent kit, coulter diff ac•t pak and coulter diff ac•t tainer medical device manufacturer, beckman coulter inc, has issued a medical device safety alert for the ac•t 8/10 series, ac•t diff™ and ac•t diff2™ hematology systems. the affected reagent part numbers and lot numbers are identified as follows: coulter ac•t pak reagent kit: reagent reference 8547110; reagent lot numbers 112079k through 112094k coulter ac•t tainer reagent, kit: reagent reference 8547111 and; reagent lot numbers113075k through 113087k coulter diff ac•t pak, 15l: reagent reference 8547134; reagent lot numbers112077k through 112097k coulter diff ac•t tainer, 4l: reagent reference 8547135; reagent lot numbers113074k through 113090k the manufacturer has received an increased number of service calls and customer complaints related to the hemoglobin (hgb) parameter on the ac‧t series analyzers. an investigation revealed that the issues may have been related to variability in a component of the diluents which in turn may lead to a film coating the inside of the wbc bath where the hgb is measured. the issue is not observed with all analyzers. the use of the diluent lots mentioned above may eventually result in a compromised wbc bath. symptoms include: failures in hgb background at startup or during a background cycle. increases in hgb incomplete computations (....). unexpected variations between the hgb & hct (hematocrit) indicated by the asterisk (*) flag have not been reported. test results are not affected. the manufacturer will take actions to address hgb issues. wbc baths are currently being replaced as needed. all new shipments of ac‧t reagents containing diluents are currently being manufactured with a component that does not exhibit this variability. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions posted on 8 september 2015.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter COULTER AcAc•T Pak Reagent Kit, COULTER AcAc•T Tainer Reagent Kit, COULTER Diff AcAc•T Pak and COULTER Diff AcAc•T Tainer
  • Manufacturer