International safety notice

Technical name: Instrument for sample preparation and processing pre-analytical phase

Brazil / Anvisa · BRA · Mar 20, 2017

Key facts

Title Technical name: Instrument for sample preparation and processing pre-analytical phase
Regulator Brazil / Anvisa
Country BRA
Brand Commercial name: cobas® 8100 Technical name: Instrument for sample preparation and processing pre-analytical phase ANVISA registration number: 10287419009 Risk class: I Affected model: BRF Module Affected serial numbers: 1508-04
Manufacturer EMPRESA DETENTORA DO REGISTRO ROCHE DIAGNÓSTICA BRASIL LTDACNPJ 30280358000186 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38 SÃO PAULO SP TEL 08007720295 FABRICANTE HITACHI HIGHTECHNOLOGIES CORPORATION 12414 NISHISHINBASHI MINATOKU TOKYO 1058717 JAPÃO
Models 1508-04, 10287419009
Date Mar 20, 2017
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models 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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