International safety notice
Urgent field safety notice for kits Simplexa HSV 1 & 2 Direct, Simplexa Flu A/B & RSV Direct and Simplexa Group A Strep Direct, Focus Diagnostics
Germany / BfArM · DEU · Apr 11, 2016
Key facts
| Title | Urgent field safety notice for kits Simplexa HSV 1 & 2 Direct, Simplexa Flu A/B & RSV Direct and Simplexa Group A Strep Direct, Focus Diagnostics |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | kits Simplexa HSV 1 & 2 Direct, Simplexa Flu A/B & RSV Direct and Simplexa Group A Strep Direct, Focus Diagnostics |
| Manufacturer | Urgent field safety notice for kits Simplexa HSV 1 & 2 Direct, Simplexa Flu A/B & RSV Direct and Simplexa Group A Strep Direct, Focus Diagnostics |
| Models | 2315092, 30782, MOL2650, MOL2150, 1-800-FDA-1088, MOL1452, 800-838-4548, 160524, 30875, 2315090, 2319288, 160497 and 6 more |
| Date | Apr 11, 2016 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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