International safety notice

Instrument for analysis of general biochemistry, hormones, drugs or proteins

Brazil / Anvisa · BRA · Jan 25, 2016

Key facts

Title Instrument for analysis of general biochemistry, hormones, drugs or proteins
Regulator Brazil / Anvisa
Country BRA
Brand Affected Products: VITROS ANALYZER SYSTEM / VITROS 4600 CHEMICAL SYSTEM / VITROS 5600 CHEMICAL SYSTEM / VITROS 5.1 FUSION CHEMICAL SYSTEM Anvisa Records: 10132590681 VITROS® 250 system (Reg ANVISA 10132590681) VITROS® 350 system (Reg ANVISA 10132590681) VITROS® 4600 Chemical System (ANVISA Reg 80145901335) VITROS® 5600 Integrated System (ANVISA Reg 80145901205) VITROS® 5.1 Fusion Chemical System (ANVISA Reg 80145900827) Risk class: II Affected Series/Lots: Includes all VITROS® 250, 350, 4600, 5600 and 5.1FS Diagnostic Systems.
Manufacturer DETENTOR DO REGISTRO JOHNSON JOHNSON DO BRASIL IND E COM DE PROD PARA SAÚDE LTDA CNPJ 54516661000101 ENDEREÇO RUA GERIVATIBA 207 MUNICÍPIO UF SÃO PAULOSP FABRICANTE ORTHO CLINICAL DIAGNOSTICS INC ENDEREÇO 100 INDIGO CREEK DRIVE MUNICÍPIO PAÍS NEW YORK EUA
Models 80145901205, 80145901335, 80145900827, 10132590681
Date Jan 25, 2016
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice

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