Reported Apr 24, 2024 · Ongoing
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Actim Oy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ACTIM OY · Klovinpellontie 3 · Espoo · N/A
Is this the product you have?
- Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
- Lot codes and dates
- UDI/DI 06430030990608, All serial numbers in distribution
- Amount recalled
- 6471 kits
Where it was sold
- Nationwide
- CT
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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