International safety notice
Alert 2925 (Technosurveillance) - Beckman Coulter - Hematological Analyzer - Family of Instruments for Cell Analysis Coulter Possibility of erroneous results with high platelet count, without system alert messages.
Brazil / Anvisa · BRA · Jul 17, 2019
Key facts
| Title | Alert 2925 (Technosurveillance) - Beckman Coulter - Hematological Analyzer - Family of Instruments for Cell Analysis Coulter Possibility of erroneous results with high platelet count, without system alert messages. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Hematological Analyzer (10033120662); Technical Name: Instrument for analyzing or counting cells and platelets; ANVISA registration number: 10033120662; Risk Class: II Affected model: Registration 10033120662: UniCel® DxH 800 Coulter® Cellular Analysis System; Numbers of series afetados: BA03001; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BECKMAN COULTER DO BRASIL COMÉRCIO E IMPORTAÇÃO DE PRODUTOS DE LABORATÓRIO LTDA CNPJ 42160812000144 AL RIO NEGRO 500 TORRE B 15º ANDAR ALPHAVILLE INDUSTRIAL BARUERI SP TEL 11 41548813 EMAIL DMWOLINGERBECKMANCOM FABRICANTE DO PRODUTO BECKMAN COULTER INC 250 SOUTH KRAEMER BOULEVARD 92821 BREA ESTADOS UNIDOS DA AMÉRICA |
| Models | BA40567, AZ41130, BA07070, BA22322, AZ41589, BC12268, BA22320, AZ43603, BA42581, 900-3, BA37557, BA35526 and 87 more |
| Date | Jul 17, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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