ACTIM OY recalls Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

Recall date

November 23, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1592-2024

FDA classification

Class II

Brand / firm

ACTIM OY

Sold / distributed

US Nationwide distribution in the state of Connecticut.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane