International safety notice
Alert 2781 (Technovigilance) - Biodina Instrumentos Cientéticos EIRELI - ABL90Flex - Possibility of parameters being reported incorrectly.
Brazil / Anvisa · BRA · Jan 21, 2019
Key facts
| Title | Alert 2781 (Technovigilance) - Biodina Instrumentos Cientéticos EIRELI - ABL90Flex - Possibility of parameters being reported incorrectly. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: ABL90 Flex Analyzer Technical Name: Instrument for analyzing blood gases, ions or pH ANVISA registration number: 10301160203 Risk Class: II Affected model: ABL90Flex 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 NITERÓI RJ TEL 21 999850440 EMAIL SYLVIOSJBIODINACOMBR FABRICANTE DO PRODUTO RADIOMETER MEDICAL APS AKANDEVEJ 21 2700 BRONSHOJ DINAMARCA |
| Models | ABL90, ABL90Flex, 10301160203 |
| Date | Jan 21, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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