International safety notice
Producto de diagnóstico in vitro de autodiagnóstico “One Step Test for SARS-CoV-2 Antigen”.
Spain / AEMPS · ESP · Jun 3, 2022
Key facts
| Title | Producto de diagnóstico in vitro de autodiagnóstico “One Step Test for SARS-CoV-2 Antigen”. |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Producto de diagnóstico in vitro de autodiagnóstico “One Step Test for SARS-CoV-2 Antigen”. |
| Manufacturer | Getein Biotech Inc., China |
| Models | 91.822.52.89, COVID-19-QUE-HAN-SIDO-DETECTADOS-EN-EL-MERCADO-Y-NO-CUMPLEN-LA-REGULACION, 28022, COV-2, SARS-COV-2, 2022-281, PFC_IVD_429 |
| Event type | Safety Notice |
| Date | Jun 3, 2022 |
| Regulator page | alertasps.aemps.es |
At a glance
- No Recall
- Yes 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