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.
What this means for you
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
- Hazard
- false-positive
- test-interference
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
Distributed nationwide across the United States.
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