Z-1592-2024 Class II Ongoing
FDA device recall Z-1592-2024 was initiated by ACTIM OY on November 23, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 6471 kits.
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