International safety notice
Alert 2771 (Technovigilance) - Ortho Clinical Diagnostics do Brasil - Vitros NT-PRO BNP Immunodiagnostic Reagent Kit - Possibility of biased results due to biotin interference.
Brazil / Anvisa · BRA · Jan 16, 2019
Key facts
| Title | Alert 2771 (Technovigilance) - Ortho Clinical Diagnostics do Brasil - Vitros NT-PRO BNP Immunodiagnostic Reagent Kit - Possibility of biased results due to biotin interference. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Vitros NT-PRO BNP Immunodiagnostic Reagent Kit Technical Name: Human brain natriuretic peptide (BNP) ANVISA registration number: 81246986791 Risk Class: II Affected model: Comp.: 100 cased wells; Affected serial numbers: 1660; |
| 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 | 81246986791 |
| 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