International safety notice
Alert 2767 (Technovigilance) - Ortho Clinical Diagnostics do Brasil Produtos para Saúde Ltda - VALP Vitros Reagent Kit - Negatively biased results when using GEN 25, in specific batches.
Brazil / Anvisa · BRA · Jan 14, 2019
Key facts
| Title | Alert 2767 (Technovigilance) - Ortho Clinical Diagnostics do Brasil Produtos para Saúde Ltda - VALP Vitros Reagent Kit - Negatively biased results when using GEN 25, in specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Valp Vitros Reagent Kit Technical Name: Valproic Acid ANVISA registration number: 81246982553 Risk Class: II Affected model: Box with 6 kits (Reagent 1: 9.7ml / Reagent 2: 4.9ml) Affected serial numbers: 25-5974, 25-6393, 25-5263, 25-5503, and 25-5727 |
| 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 | 25-5727, 25-5503, 25-5974, 25-6393, 81246982553, 25-5263 |
| Date | Jan 14, 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