Actim PROM dipstik, REF 30831ETUS recallZ-1592-2024 · Actim Oy · initiated Nov 23, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Actim Oy or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1592-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 23, 2023
- Posted by the FDA
- Apr 17, 2024
- Recalling firm
- Actim Oy
- Quantity
- 6471 kits
- Product code
- OAM
- FDA submissions
- K123986
- Distribution
- US Nationwide distribution in the state of Connecticut.
Product description
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Code information (models, lots, serial numbers)
UDI/DI 06430030990608, All serial numbers in distribution
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Actim PROM 30821ETUSActim Oy · Immunoassay, Insulin-Like Growth Factor Binding Protein-11 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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