Device product
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Z-1592-2024
Product summary
- Firm
- ACTIM OY
- Event
- Event 93845
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6471 kits
- Official record key
device-enforcement:Z-1592-2024
Official wording
Reason: Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.
Code information: UDI/DI 06430030990608, All serial numbers in distribution
Distribution pattern: US Nationwide distribution in the state of Connecticut.
Derived failure modes
-
Unknown
Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.