International safety notice
Alert 2784 (Technovigilance) - Biodina Instrumentos Cientificos Eireli - ABL8X7 - Possibility of Creatinine results lower than expected in patient samples.
Brazil / Anvisa · BRA · Jan 22, 2019
Key facts
| Title | Alert 2784 (Technovigilance) - Biodina Instrumentos Cientificos Eireli - ABL8X7 - Possibility of Creatinine results lower than expected in patient samples. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: ABL8X7 Technical Name: Blood Gas Analyzer ANVISA registration number: 10301160158 Risk Class: I Affected model: ABL800Flex Affected serial numbers: See attachment List of serial numbers at risk |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIODINA INSTRUMENTOS CIENTÍFICOS EIRELI CNPJ 29375441000150 RUA JOSÉ CLEMENTE 90PARTE 24020105 NITERÓI RJ EMAIL SYLVIOSJBIODINACOMBR FABRICANTE DO PRODUTO RADIOMETER MEDICAL APS AKENDEVEJ 21 2700 BRONSHOJ DINAMARCA |
| Models | ABL800Flex, ABL8X7, 10301160158 |
| Date | Jan 22, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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