International safety notice
Urgent Field Safety Notice for GenomEra molecular analyzer, GenomEra CDX System by Abacus Diagnostica Oy
Germany / BfArM · DEU · May 25, 2023
Key facts
| Title | Urgent Field Safety Notice for GenomEra molecular analyzer, GenomEra CDX System by Abacus Diagnostica Oy |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | GenomEra molecular analyzer, GenomEra CDX System |
| Manufacturer | Abacus Diagnostica Oy |
| Models | 2023-02-22_FSN_005_DISTRIBUTOR, CDX-70-01-40, CDX-170-01-20, 2023-02-22_, CDX-110-01-40, CDX-160-01-40, CDX-140-01-40, CDX-10-020, 2023-02-22, 20120038, 20200164, 31.03.2023 and 40 more |
| Date | May 25, 2023 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No 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