Actim PROM Dipstick – Lubricant Interference (2023)
Personal lubricants can interfere with test results, potentially causing false positive readings.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Brand
ACTIM OY Klovinpellontie 3 Espoo Finland
Lot Codes / Batch Numbers
UDI/DI 06430030990608, All serial numbers in distribution
Products Sold
UDI/DI 06430030990608, All serial numbers in distribution
ACTIM OY Klovinpellontie 3 Espoo Finland is recalling Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane due to Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Actim Oy issued a MEDICAL DEVICE RECALL notice to its sole distributor on 11/23/2023 via email. The notice explained the issue, potential risk, and requested that users refrain from using surgical lubricants when collecting the vaginal specimen and that vaginal specimens do not contain significant amounts of personal lubricant from patient's recent personal use. The instructions for use will be updated according to the latest test results of surgical and personal lubricant interference. In the interim, a separate note will be included in the test kit regarding the correction of the interference claims and guidance of lubricant use.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026