International safety notice
In-Vitro Diagnostic Medical Device for Detection of SARS-CoV-2 Antibody (coloidal gold inmunochromatography). Model: COVID19 INSTATEST (self-testing: 1 test per box).
Spain / AEMPS · ESP · Aug 3, 2023
Key facts
| Title | In-Vitro Diagnostic Medical Device for Detection of SARS-CoV-2 Antibody (coloidal gold inmunochromatography). Model: COVID19 INSTATEST (self-testing: 1 test per box). |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | In-Vitro Diagnostic Medical Device for Detection of SARS-CoV-2 Antibody (coloidal gold inmunochromatography). Model: COVID19 INSTATEST (self-testing: 1 test per box). |
| Manufacturer | Beijing Lepu Medical Technology Co. Ltd, China |
| Models | 2023-06-27, 2023EL, 98179, COVID19, 80339, V1.18.02.03496.002FABRICANTE, 28022, 2023PUEDE, 102200, 2020FECHA, 91.822.52.89, V1.18.02.03496.002 and 6 more |
| Event type | Safety Notice |
| Date | Aug 3, 2023 |
At a glance
- No Recall
- Yes Field safety notice
- 1–9 Matching device models 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