ACTIM recalls PROM dipstik (REF 308:31ETUS) due to false positives from vaginal lubricants. This may lead to incorrect pregnancy test results. Affected units include all serial numbers in distribution.
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.
ACTIM is recalling its PROM dipstik test for rupture of fetal membranes because vaginal lubricants can cause false positive results. This means the test might incorrectly indicate a rupture when there isn't one, potentially causing unnecessary medical concern.
The test can give a false positive result if vaginal lubricants are present in the sample. This happens because lubricants interfere with the immunoassay process, leading to incorrect readings that might suggest a rupture when there isn't one.
Pregnant women using the Actim PROM dipstik test for fetal membrane rupture are most at risk. The test is used during pregnancy to check for premature rupture of membranes.
The product is labeled 'Actim PROM dipstik, REF 30831ETUS'. All units with serial numbers in the distribution range are affected. The test is used for checking fetal membrane rupture during pregnancy.
Look for the serial number on the test packaging or label to confirm if it's affected.
If you have the test, use a different pregnancy test or consult your healthcare provider for an alternative method.
The test can give false positive results if vaginal lubricants are present in the sample, which may lead to incorrect readings about fetal membrane rupture.
The product is labeled 'Actim PROM dipstik, REF 30831ETUS' with serial numbers in the distribution range.
Check the serial number to confirm if it's affected. If so, use an alternative test or consult your healthcare provider.
We’ve drafted a message you can send ACTIM to request your refund or repair — edit it as you like.
Subject: Recall Z-1592-2024 — ACTIM ACTIM Hello, I own a ACTIM that is covered by recall Z-1592-2024 from ACTIM. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
