Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1592-2024 — Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

U.S. FDA — Device Enforcement · Finland · 2023-11-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1592-2024
Date of alert
2023-11-23
Country / jurisdiction
Finland
Risk level
Class II
Risk type
recall
Brand
ACTIM OY
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
06430030990608
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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