International safety notice
Alert 2775 (Technovigilance) - Ortho Clinical Diagnostics do Brasil Produtos para Saúde Ltda - Vitros dLDL Reagent Kit - Possibility of biased results for specific batches.
Brazil / Anvisa · BRA · Jan 16, 2019
Key facts
| Title | Alert 2775 (Technovigilance) - Ortho Clinical Diagnostics do Brasil Produtos para Saúde Ltda - Vitros dLDL Reagent Kit - Possibility of biased results for specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Vitros dLDL Reagent Kit Technical Name: LOW DENSITY LIPOPROTEIN (LDL) ANVISA registration number: 81246986700 Risk Class: Class II Affected model: Box with 6 kits (Reagent 1: 18.9mL/ Reagent 2: 6.0mL) Affected serial numbers: 255777, 25-6057, 25-6240, 26-6396, 26-6582, and 26-6639 |
| 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 | 25-6240, 26-6639, 26-6396, 26-6582, 25-6057, 255777, 81246986700 |
| Date | Jan 16, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 100–999 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