Events

Alerta De Seguridad para IMMUNOSORBENT ASSAY TEST KITS (IMMUNOSORBENT ASSAY TEST KITS) IMMUNOSORBENT SAMPLES TEST KITS: PRIMARY RUBEOLA IMMUNOGLOBULIN G ENZYME-LINKED IMMUNOSORBENT ASSAY TEST KITS: PRODUCT NO. RBE100; LOT NO. RBE100.002

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MERIDIAN DIAGNOSTICS 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
  • ID del evento
    149
  • Fecha
    2001-10-13
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The reference control of the test kits mentioned does not meet the specifications, which could lead to false-negative results. the manufacturer started a removal by correspondence dated july 21, 2001.
  • Acción
    MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF JULY 21, 2001 AND THE MERIDIAN DIAGNOSTICS KNOWLEDGE FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. MERIDIAN DIAGNOSTICS AFFIRMS THAT CONSUMERS SHOULD DISCONTINUE THE USE OF THESE KITS AND DISCARD THEM. MERIDIAN DIAGNOSTICS ALSO SAYS THAT KIT DISTRIBUTORS MUST DISCONTINUE YOUR DISTRIBUTION, NOTIFY REMOVAL CONSUMERS, AND PROVIDE A COPY OF THE KNOWLEDGE FORM. FILL IN THE KNOWLEDGE FORM AND FAX FOR MERIDIAN DIAGNOSTICS ON PHONE (513) 272-5432. MERIDIAN DIAGNOSTICS WILL REPLACE ANY PRODUCT AFFECTED BY A REPLACEMENT KIT, WITHOUT ADDITIONAL COSTS. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR MERIDIAN DIAGNOSTICS REPRESENTATIVE.

Device

IMMUNOSORBENT ASSAY TEST KITS (IMMUNOSORBENT ASSAY TEST KITS) IMMUNOSORBENT SAMPLES TEST KITS: PR...

Manufacturer

MERIDIAN DIAGNOSTICS INC
  • Source
    ANVSANVISA