Class II
Medical Device Recall: Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
ACTIM OY · November 23, 2023
Reason for Recall
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.
States Affected
NATIONWIDE
Quantity Affected
6471 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1592-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.