ACTIM OY is recalling approximately 6,471 units of the Actim PROM dipstik, a rapid diagnostic test used to detect the rupture of fetal membranes (PROM) in pregnant women. Testing has revealed that the presence of personal lubricants in a vaginal specimen can interfere with the results, causing the test to show a false positive. This recall affects all serial numbers for the dipstik kits (REF 30831ETUS) distributed across the United States, specifically in Connecticut. Consumers should be aware that incorrect test results could lead to unnecessary medical interventions or misdiagnosis.
The use of personal lubricants may interfere with the test's immunoassay, producing a false positive result that incorrectly indicates a rupture of the fetal membrane. This could lead to inappropriate clinical management of pregnancy, such as unnecessary hospitalizations or medical procedures.
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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