International safety notice
Alert 2786 (Technovigilance) - Biodina Instrumentos Cientéticos Eireli - AQT90Flex - Possibility that the internal temperature of the device is above acceptable.
Brazil / Anvisa · BRA · Jan 22, 2019
Key facts
| Title | Alert 2786 (Technovigilance) - Biodina Instrumentos Cientéticos Eireli - AQT90Flex - Possibility that the internal temperature of the device is above acceptable. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: AQT90 Flex Analyzer Technical Name: Instrument intended for immunoassays ANVISA registration number: 10301160185 Risk Class: I Affected model: AQT90Flex Affected serial numbers: 838R0154N002; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIODINA INSTRUMENTOS CIENTÍFICOS EIRELI CNPJ 29375441000150 RUA JOSÉ CLEMENTE 90PARTE NITERÓI RJ EMAIL SYLVIOSJBIODINACOMBR FABRICANTE DO PRODUTO RADIOMETER MEDICAL APS DINAMARCA |
| Models | 838R0341N017, 838R0226N009, 10301160185, 838R0347N001, 838R0303N014, 838R0226N001, 838R0326N008, 838R0303N011, 838R0303N022, 838R0347N006, 838R0303N016, 838R0343N011 and 16 more |
| 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