FDA Device recall Z-1592-2024
Actim PROM dipstik, REF 30831ETUS
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Actim PROM dipstik, REF 30831ETUS by Actim Oy, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1592-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-23 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Actim Oy |
| Distribution | US |
Product
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Reason
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.
Identifiers
| code_info | UDI/DI 06430030990608, All serial numbers in distribution |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1592-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.