International safety notice
- COVID-19 IgG/IgM Rapid Test Device; - SARS-CoV-2 One Step Rapid Test Device; - Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
Spain / AEMPS · ESP · Sep 18, 2020
Key facts
| Title | - COVID-19 IgG/IgM Rapid Test Device; - SARS-CoV-2 One Step Rapid Test Device; - Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | - COVID-19 IgG/IgM Rapid Test Device; - SARS-CoV-2 One Step Rapid Test Device; - Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) |
| Manufacturer | Medakit Ltd. 367-375 Queen’s Road, Central, Sheung Wong, Hong Kong. |
| Models | 71-75, DEVICESARS-COV-2, “COVID-19, SARS-COV-2, 91.822.52.89, PRODUCTOSCOVID-19, 2019-NCOV, 19-QUE-HAN-SIDO-DETECTADOS-EN-EL-MERCADO-Y-NO-CUMPLEN-LA-REGULACION, “SARS-COV-2, 40239, COVID-19, 367-375 and 3 more |
| Event type | Safety Notice |
| Date | Sep 18, 2020 |
| Regulator page | alertasps.aemps.es |
At a glance
- No Recall
- Yes Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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