International safety notice
Alert 2795 (Technovigilance) - Ortho Clinical Diagnóstics do Brasil Produtos para Saúde Ltda - Vitros Immunodiagnostic Calibrator for Myoglobin - Possibility of calibration failures and biased results.
Brazil / Anvisa · BRA · Feb 7, 2019
Key facts
| Title | Alert 2795 (Technovigilance) - Ortho Clinical Diagnóstics do Brasil Produtos para Saúde Ltda - Vitros Immunodiagnostic Calibrator for Myoglobin - Possibility of calibration failures and biased results. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Vitro Immunodiagnostic Calibrator for Myoglobin Technical Name: Myoglobin ANVISA registration number: 81246986667 Risk Class: II Affected model: 3 sets with calibrators levels 1,2 and 3 for 1 ml each Affected serial numbers: 1310; |
| 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 ORTHOCLINICAL DIAGNOSTICS FELINDRE MEADOWS PENCOED BRIDGEND CF35 5PZ REINO UNIDO |
| Models | 81246986667 |
| Date | Feb 7, 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