International safety notice

Technical name: Device for identification/antibiogram of microorganisms

Brazil / Anvisa · BRA · Jan 16, 2018

Key facts

Title Technical name: Device for identification/antibiogram of microorganisms
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: VITEK 2 AST Family Technical name: Device for identification/antibiogram of microorganisms ANVISA registration number: 10158120592 Risk class: II Affected model: VITEK 2 AST P585 and VITEK 2 AST P612 Affected serial numbers: Field action is not batch dependent.
Manufacturer EMPRESA DETENTORA DO REGISTRO BIOMPERIEUX BRASIL IND E COM DE PROD LABORATORIAIS LTDA CNPJ 33040635000171 ESTRADA DO MAPUÁ 491 LOTE 1 TAQUARA RIO DE JANEIRO RJ FABRICANTE BIOMÉRIEUX INC 595 ANGLUM ROAD HAZELWOOD MISSOURI USA 63042 TELEFONE 33 4 78 87 76 67 EMAIL JEFFSCANLANBIOMERIEUXCOM
Models 10158120592
Date Jan 16, 2018
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 10–99 Matching device models in FDA data
  • 10–99 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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