FDAFDA · Food and drugs·Recall number Z-1592-2024
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Published April 24, 2024 · Recall initiated: November 23, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- ACTIM OY
- Distributor
- US Nationwide distribution in the state of Connecticut.
- Lot
- UDI/DI 06430030990608, All serial numbers in distribution
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Finland
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