Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
This recall is currently active, issued April 17, 2024. It was issued by Actim Oy Klovinpellontie 3 Espoo Finland.
- Recall Initiated
- November 23, 2023
- Posted
- April 17, 2024
- Recall Number
- Z-1592-2024
- Quantity
- 6471 kits
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of Connecticut.
Lot / Code Info
UDI/DI 06430030990608, All serial numbers in distribution
Root Cause
Under Investigation by firm
Action Taken
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.