International safety notice
Alert 2962 (Technosurveillance) - Ortho Clinical - Ortho Vision Max 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 2962 (Technosurveillance) - Ortho Clinical - Ortho Vision Max 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 Max Analyzer Technical Name: Instrument intended for immunoassays ANVISA registration number: 81246980040 Risk Class: II Affected model: Ortho Vision Max Analyzer Affected serial numbers: 80002216; |
| 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 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 FELINDRE MEADOWS PENCOED BRIDGEND CF35 5PZ ESTADOS UNIDOS DA AMÉRICA REINO UNIDO |
| Models | 81246980040, 80002365, 80002404, 80002216 |
| Date | Aug 21, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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