International safety notice
Alert 2961 (Technosurveillance) - Ortho Clinical - Ortho Vision Analyzer - Possibility of spilling fluids into adjacent tubes, vials or wells, causing contamination of the sample, dilution tray or reagent.
Brazil / Anvisa · BRA · Aug 21, 2019
Key facts
| Title | Alert 2961 (Technosurveillance) - Ortho Clinical - Ortho Vision Analyzer - Possibility of spilling fluids into adjacent tubes, vials or wells, causing contamination of the sample, dilution tray or reagent. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Ortho Vision Analyzer Technical Name: Instrument for analysis of general biochemistry, hormones, drugs or proteins ANVISA registration number: 81246986612 Risk Class: II Affected model: Ortho Vision Analyzer Affected serial numbers: 60002257; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ORTHO CLINICAL DIAGNÓSTICS 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 FELINDRE MEADOWS PENCOED BRIDGEND CF35 5PZ REINO UNIDO |
| Models | 60002896, 60002257, 60002895, 60002258, 60002255, 60003262, 60003094, 60002247, 60003520, 81246986612, 60003746, 60003386 and 1 more |
| Date | Aug 21, 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