International safety notice

Alert 2514 (Technosurveillance) - Diamed - ID-DIAPANEL - Equipment is unable to read the red blood cell vial - test.

Brazil / Anvisa · BRA · Mar 12, 2018

Key facts

Title Alert 2514 (Technosurveillance) - Diamed - ID-DIAPANEL - Equipment is unable to read the red blood cell vial - test.
Regulator Brazil / Anvisa
Country BRA
Brand Commercial name: Id-Diapanel Technical name: Immunohematology - Red Blood Cell Reagents / Red Blood Cells treated with enzymes ANVISA registration number: 80004040131 Risk class: Affected model: 00 000 000 0041 14 Affected serial number: ID-DiaPanel Kit Lot: 45161.03.1 Lote da hemácia-teste "ID-DiaPanel 2": 06181.03.1
Manufacturer EMPRESA DETENTORA DO REGISTRO DIAMED LATINO AMÉRICA SA CNPJ 71015853000145 RUA ALFREDO ALBANO DA COSTA 100 DISTRITO INDUSTRIAL LAGOA SANTA MG FABRICANTE DIAMED LATINO AMÉRICA SA RUA ALFREDO ALBANO DA COSTA 100 DISTRITO INDUSTRIAL LAGOA SANTA MG TELEFONE 31 36896637 EMAIL BRZRABIORADCOM
Models 80004040131, 06181.03.1, 45161.03.1
Date Mar 12, 2018
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data
  • 1–9 Matching catalog numbers in FDA data

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About International device safety notices

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