International safety notice

Technical name: Equipment for Immunohematology

Brazil / Anvisa · BRA · Dec 21, 2016

Key facts

Title Technical name: Equipment for Immunohematology
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Ortho Vision Analyzer Technical name: Equipment for Immunohematology ANVISA registration number: 80145901739 Risk class: I Affected model: Ortho Vision Analyzer Affected serial numbers: ORTHO VISION® Analyzer for ORTHO BioVue® Cassettes, product code 6904579, version of software 3.6.0 and earlier, Serial Number 60002256 and 60002257.
Manufacturer EMPRESA DETENTORA DO REGISTRO JOHNSON JOHNSON DO BRASIL IND E COM DE PROD PARA SAÚDE LTDA CNPJ 54516661000101 LOCALIZADA NA AV JUSCELINO KUBITSCHEK Nº 2041 ANDARES 8º E 9º COMPLEXO JK BLOCO B SÃO PAULO SP FABRICANTE ORTHOCLINICAL DIAGNOSTICS INC FELINDRE MEADOWS PENCOED BRIDGEND CF35 5PZ REINO UNIDO0
Models 6904579, 60002256, 60002257, 80145901739, 3.6.0
Date Dec 21, 2016
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice

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