International safety notice
Alert 2782 (Technovigilance) - Biodina Instrumentos Cientéticos Eireli - ABL800 - Transmission of incomplete information to the LIS/HIS or middleware system.
Brazil / Anvisa · BRA · Jan 21, 2019
Key facts
| Title | Alert 2782 (Technovigilance) - Biodina Instrumentos Cientéticos Eireli - ABL800 - Transmission of incomplete information to the LIS/HIS or middleware system. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: ABL800 Technical Name: Instrument for analyzing blood gases, ions or pH ANVISA registration number: 10301160150 Risk Class: II 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 | 10301160150, ABL800, ABL800Flex |
| Date | Jan 21, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1,000+ Matching device models in FDA data
- 1,000+ 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