International safety notice
Alert 2772 (Technosurveillance) - Ortho Clinical - Vitros 5.1 Fusion Chemical System;
Brazil / Anvisa · BRA · Jan 16, 2019
Key facts
| Title | Alert 2772 (Technosurveillance) - Ortho Clinical - Vitros 5.1 Fusion Chemical System; |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Vitros 5.1 Fusion Chemical System (81246986607); Technical Name: Instrument for analysis of general biochemistry, hormones, drugs or proteins (81246986607, 81246986608 and 81246982491); ANVISA registration number: 81246986607; Risk Class: II Affected model: Equipment with software versions 3.0 or earlier; Affected serial numbers: Registration: 81246986607; Registration: 81246986608; Registration: 81246982491; Registration: 81246984632; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ORTHO CLINICAL DIAGNOSTICS DO BRASIL PRODUTOS PARA SAÚDE LTDA CNPJ 21921393000146 AVENIDA DOUTOR CHUCRI ZAIDAN 920 7 ANDAR SÃO PAULO SP TEL 11 28882951 EMAIL LARISSAMELLOORTHOCLINICALDIAGNOSTICSCOM FABRICANTE DO PRODUTO ORTHO CLINICAL DIAGNOSTICS INC 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 ESTADOS UNIDOS DA AMÉRICA |
| Models | 56000413, 56001733, 34002172, 34002201, 34000605, 56001290, 56001930, 46000509, 36000406, 56001680, 34002125, J56003262 and 197 more |
| Date | Jan 16, 2019 |
| 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