Events

Alerta De Seguridad para AxSYM Solution 4 (Dilution Buffer) in Opiate AxSYM Assays. Batches: 81865M300, 81870M300, 81870M300, 81870M300, 81870M300, 81874M300, 81874M300,81873M300, 81871M300, 79809M101, 80074M200, 80075M200, 80296M100, 80072M200,8030M100, 81241M100, 81242M100, 81244M100, 81243M100, 81014M300, 81621M100,81827M300, 81013M300, 81028M300, 81830M300, 81030M300, 81843M300, 81844M300, 81869M300, 81845M300, 81846M300, 81851M300, 81022M300, 81027M300, 81038M300, 81040M300, 81854M300, 81852M300, 81023M300, 81024M300, 81025M300, 81041M300 ,. 81831M300, 81832M300, 81839M300, 81840M300, 81841M300, 81855M300 ,. 81856M300,81857M300, 81860M300, 81861M300, 81862M300 and 81026M300.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATORIES OF BRAZIL LTDA.

¿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
  • ID del evento
    648
  • Fecha
    2002-01-10
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    Batch numbers 80074M200, 80075M200, 800845M300,81872M300, 81873M300 and 81874M300 received in Brazil are kept in quarantine until disruption. (Abbott Laboratories Brazil)
  • Causa
    Voluntary notification --- existence of 02 product problems when using one of the identified batches of axsym solution 4 (dilution buffer). - during the calibration of the axsym opiates assay, customers obtained error code 1016. (error in calibration, polarization of cal a very small), and code 1076 (calibration error, calibrators loaded incorrectly). in addition, complaints indicate that when batches are used and the opiate test is performed using a stored calibration curve, all levels of test controls fall out of the high range. - there is potential to generate false positive opiates results, and falsely high opiates results generally when using one of the batches. this can occur when patient results are generated from a stored calibration curve and the controls were not analyzed in the same run.
  • Acción
    Client communication was not made because there are no clients in Brazil affected by this occurrence. The material received was promptly segregated and awaits destruction procedure. Note: lots 80074M200, 80075M200, 800845M300,81872M300, 81873M300 and 81874M300 received in Brazil are kept in quarantine until destruction. (Abbott Laboratories Brazil)

Device

AxSYM Solution 4 (Dilution Buffer) in Opiate AxSYM Assays. Batches: 81865M300, 81870M300, 81870M3...

Manufacturer

ABBOTT LABORATORIES OF BRAZIL LTDA
  • Source
    ANVSANVISA