Fetal Membrane Rupture Test Kits Recalled for False Positive Results
Actim PROM dipstik fetal membrane rupture test kits are recalled because personal lubricants can interfere with the test, producing false positive results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a diagnostic test where personal lubricants can cause false positive results, presenting a risk of unnecessary medical intervention. No illnesses or injuries have been reported, qualifying it as High severity under the rubric for risk-of-harm products without reported injury.
Plain-English summary
The Actim PROM dipstik (REF 30831ETUS) is a qualitative immunoassay rapid test designed to detect rupture of fetal membranes. A total of 6,471 kits have been recalled by ACTIM OY.
Testing has shown that personal lubricants present in vaginal specimens can interfere with test performance, resulting in false positive readings. A false positive result would incorrectly indicate that membrane rupture has occurred when none has actually taken place.
The recalled kits were distributed nationwide in the United States, including Connecticut. Patients and healthcare providers who have used or possess these kits should discontinue use and consult their healthcare provider. Affected units can be identified by UDI/DI 06430030990608; all serial numbers within this distribution are subject to the recall.
The recalled product
- Product
- Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
- Manufacturer
- ACTIM OY
- Category
- Medical Device — Diagnostic Test
- Affected units
- 6,471
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 06430030990608
- All serial numbers in distribution
Distribution
Related recalls
Same hazard · false positive
See all →- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighpTau 217 plasma calibrators recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
Similar recalls
- HighClinical Innovations Recalls ROM Plus Collection Kits Due to Swab Defect
FDA (Devices) · 2020-12-16
- HighSiemens Rubella IgM Assay Recalled for False Positive Results
FDA (Devices) · 2016-10-19
- SevereQiagen AmniSure ROM Test Recalled for Potential Control Line Failure
FDA (Devices) · 2018-08-15
- SevereAbbott Respiratory Diagnostic Kit Recalled for Potential False Positive Results
FDA (Devices) · 2021-10-20
- HighDiagnostic Kit Recalled for False Positive Bacterial Identification Results
FDA (Devices) · 2022-12-07
- HighSiemens IMMULITE 2000 Progesterone Test Kits Recalled for False Results
FDA (Devices) · 2017-03-15