Z-1592-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2024
- Initiation Date
- November 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6471 kits
Product Description
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
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 Pattern
US Nationwide distribution in the state of Connecticut.
Code Information
UDI/DI 06430030990608, All serial numbers in distribution