FDA-Device2024-04-24Class II
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
ACTIM OY
Hazard
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.
Sold states
US Nationwide distribution in the state of Connecticut.
Affected count
6471 kits
Manufactured in
Klovinpellontie 3, Espoo, Finland
Products
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1592-2024Don't want to check this manually?
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