FDA recall Z-1592-2024

Product

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

US Nationwide distribution in the state of Connecticut.

Key facts

Status

Ongoing

Initiation date

2023-11-23

Report date

2024-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Espoo, Finland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1592-2024