ACTIM OY: Medical Device Recall in 2024 - (Recall #: Z-1592-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 23, 2023

Date Posted: April 24, 2024

Recall Number: Z-1592-2024

Event ID: 93845

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.

Status: Ongoing

Product Quantity: 6471 kits

Code Information:

UDI/DI 06430030990608, All serial numbers in distribution

Distribution Pattern:

US Nationwide distribution in the state of Connecticut.

Voluntary or Mandated:

Voluntary: Firm initiated