Events

Retiro De Equipo (Recall) de Device Recall Bayer brand A1CNow MULTITEST A1C SYSTEM TEST KITS

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Bayer Healthcare Llc.

¿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
    66101
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0136-2014
  • Fecha de inicio del evento
    2013-08-26
  • Fecha de publicación del evento
    2013-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121482
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Assay, glycosylated hemoglobin - Product Code LCP
  • Causa
    Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.
  • Acción
    Bayer Healthcare sent an Urgent Medical Device Recall letter dated August 26, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and quarantine any affected product. Complete the attached Recall Response Form and fax to Bayer Customer Service. Customers were instructed to use the attached letter to notify affected next level customers of the recall. For questions regarding this recall call 408-524-2255, ext 290.

Device

Device Recall Bayer brand A1CNow MULTITEST A1C SYSTEM TEST KITS
  • Modelo / Serial
    Lot: 1300733 (US, China);  Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan)
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.
  • Descripción del producto
    Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by || Bayer HealthCare LLC, Sunnyvale, CA || The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.
  • Manufacturer
    Bayer Healthcare Llc

Manufacturer

Bayer Healthcare Llc
  • Dirección del fabricante
    Bayer Healthcare Llc, 510 Oakmead Pkwy, Sunnyvale CA 94085-4022
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    USFDA