ACTIM OY 2024-04-24 Health serious FDA
Health · FDA · Recall #FDA-Z-1592-2024
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of… Recall
Issued April 24, 2024 · ACTIM OY
In April 2024, ACTIM OY recalled the Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact ACTIM OY to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- ACTIM OY
- Category
- Health
- Recall date
- April 24, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the state of Connecticut.
- Recall number
- FDA-Z-1592-2024
- Made in
- Finland
- Issuing agency
- FDA
In context
- ACTIM OY has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.