FDA Enforcement
Class II
Ongoing
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Recall: Z-1592-2024
·
Reported April 24, 2024
Enforcement
- Recall Number
- Z-1592-2024
- Event ID
- 93845
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ACTIM OY
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- April 24, 2024
- Initiation Date
- November 23, 2023
- Classification Date
- April 17, 2024
- Address
- Klovinpellontie 3, Espoo, N/A, Finland
Description
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
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 Info
UDI/DI 06430030990608, All serial numbers in distribution
Distribution
US Nationwide distribution in the state of Connecticut.
Quantity
6471 kits