International safety notice

Alert 2526 (Technosurveillance) - bioMerieux - VIDAS - Automated System for Executing Laboratory Diagnostic Tests Device pipetting failures can affect the volume of the pipetted patient sample.

Brazil / Anvisa · BRA · Mar 19, 2018

Key facts

Title Alert 2526 (Technosurveillance) - bioMerieux - VIDAS - Automated System for Executing Laboratory Diagnostic Tests Device pipetting failures can affect the volume of the pipetted patient sample.
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: VIDAS - Automated System for Executing Laboratory Diagnostic Tests Technical name: Instrument intended for immunoassays ANVISA registration number: 10158120241 Risk class: I Affected model: VIDAS / miniVIDAS System / VIDAS System / miniVIDAS Affected serial number: This field action is not batch dependent.
Manufacturer EMPRESA DETENTORA DO REGISTRO BIOMERIEUX BRASIL IND E COM DE PROD LABORATORIAIS LTDA CNPJ 33040635000171 ESTRADA DO MAPUÁ 491 LOTE 1 TAQUARA RIO DE JANEIRO RJ FABRICANTE BIOMERIEUX SA F 69280 MARCY LETOILE FRANÇA TELEFONE 33 4 78877667 EMAIL CHRISTINEFERRYBIOMERIEUXCOM
Models 10158120241
Date Mar 19, 2018
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 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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