International safety notice

Technical name: Activated Clotting Time

Brazil / Anvisa · BRA · Jan 23, 2018

Key facts

Title Technical name: Activated Clotting Time
Regulator Brazil / Anvisa
Country BRA
Brand Nome comercial: i-STAT KAOLIN ACT CARTRIDGE Technical name: Activated Clotting Time ANVISA registration number: 80146501500 Risk class: III Affected model: Not applicable. Affected serial numbers: R16354A;
Manufacturer EMPRESA DETENTORA DO REGISTRO ABBOTT LABORATÓRIOS DO BRASIL LTDA CNPJ 56998701000116 RUA MICHIGAN 735 CIDADE MONÇÕES SÃO PAULO SP FABRICANTE ABBOTT LABORATORIES 100 ABBOTT PARK ROAD ABBOTT PARK ILLINOIS 60064 USA TELEFONE 1 6094549272 FAX 1 6094199370 EMAIL LARRY KRASLEY
Models R17201, 80146501500, R17250, R17123, R16115, R16067, R15310, R17197, R16222, R16146, R17276, R16304 and 20 more
Date Jan 23, 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

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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