Actim PROM dipstik — Class II medical device recall Z-1592-2024
Ongoing recall by ACTIM OY, reported 2024-04-24, distributed nationwide. Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere
| Recall number | Z-1592-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ACTIM OY, Espoo, Finland |
| Recall initiated | 2023-11-23 |
| Classified | 2024-04-17 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 6,471 kits |
| UPC / GTIN / UDI-DI | 06430030990608 |
| Model numbers | 30831ETUS |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1592-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.