International safety notice
One Step Rapid Diagnostic Test; One Step HIV 1+2 Test (Strip C10-11, Cassette C10-20); One Step HBsAg Test (Strip B11-11, Cassette B11-20); One Step HCV Test (Strip B20-11, Cassette B20-20)
Spain / AEMPS · ESP · Sep 29, 2023
Key facts
| Title | One Step Rapid Diagnostic Test; One Step HIV 1+2 Test (Strip C10-11, Cassette C10-20); One Step HBsAg Test (Strip B11-11, Cassette B11-20); One Step HCV Test (Strip B20-11, Cassette B20-20) |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | One Step Rapid Diagnostic Test; One Step HIV 1+2 Test (Strip C10-11, Cassette C10-20); One Step HBsAg Test (Strip B11-11, Cassette B11-20); One Step HCV Test (Strip B20-11, Cassette B20-20) |
| Manufacturer | Core Technology Co., Ltd, China |
| Models | B11-20, 2022-IVD, LFO_IVD_709, 2023-456, QS-007FABRICANTE, C10-20, 28022, 91.822.52.89, 102206, B20-11, B11-11, C10-11 and 3 more |
| Event type | Safety Notice |
| Date | Sep 29, 2023 |
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