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ACTIM OY recalls Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Recalled April 24, 2024 · FDA recall Z-1592-2024 · 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. · FDA Class II
Units
6471 kits
Sold at
US Nationwide distribution in the state of Connecticut.
Description
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.
Product
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Manufacturer(s)
ACTIM OY
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →