Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - DAT PERFORMANCE VERIFIERS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ORTHO-CLINICAL DIAGNOSTICS.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    78604
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-09-21
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Ortho clinical diagnostics has initiated this recall due to the potential to obtain lower than expected quality control (qc) results for vitros benz reagent using specific lots of vitros dat performance verifiers. if the issue occurs qc results for benz may be at or below ortho's range of means as defined in the assay sheets. this issue may lead to an inability to verify calibration or cause failures in daily qc results.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - DAT PERFORMANCE VERIFIERS
  • Modelo / Serial
    Model Catalog: 680 2328 (Lot serial: M5620); Model Catalog: 680 2329 (Lot serial: M5620); Model Catalog: 680 2331 (Lot serial: L5619); Model Catalog: 680 2330 (Lot serial: L5619); Model Catalog: 680 2329 (Lot serial: L5619); Model Catalog: 680 2328 (Lot serial: L5619); Model Catalog: 680 2327 (Lot serial: L5619); Model Catalog: 680 2331 (Lot serial: K5618); Model Catalog: 680 2330 (Lot serial: K5618); Model Catalog: 680 2329 (Lot serial: K5618); Model Catalog: 680 2328 (Lot serial: K5618); Model Catalog: 680 2327 (Lot serial: K5618); Model Catalog: 680 2331 (Lot serial: J5617); Model Catalog: 680 2330 (Lot serial: J5617); Model Catalog: 680 2329 (Lot serial: J5617); Model Catalog: 680 2328 (Lot serial: J5617); Model Catalog: 680 2327 (Lot serial: J5617); Model Catalog: 680 2331 (Lot serial: H5616); Model Catalog: 680 2330 (Lot serial: H5616); Model Catalog: 680 2329 (Lot serial: H5616); Model Catalog: 680 2328 (Lot serial: H5616); Model Catalog: 680 2327 (Lot serial: H5616); Model Catalog: 680 2331 (Lot seri
  • Descripción del producto
    VITROS CHEMISTRY PRODUCTS 5 1 FS CHEMISTRY SYST
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS