Espoo, Finland
ACTIM OY recalls
1 recall recorded since 2018, most recently on 23 November 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 November 2023
- 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.
- Distribution
- US Nationwide distribution in the state of Connecticut.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1592-2024
- Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.