# FDA recall Z-1592-2024

> **ACTIM OY** · Class II · device recall initiated 2023-11-23.

## Product

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

## 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.

## Key facts

- **Recall number:** Z-1592-2024
- **Recalling firm:** ACTIM OY
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-23
- **Report date:** 2024-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Espoo, Finland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1592-2024

## Citation

> AI Analytics. FDA recall Z-1592-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1592-2024. Source: US FDA. Licensed CC0.

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