Actim PROM dipstik recall
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Why was Actim PROM dipstik 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 06430030990608, All serial numbers in distribution
- Product
- Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
- Recalling firm
- ACTIM OY
- Quantity
- 6471 kits
- Distribution
- US Nationwide distribution in the state of Connecticut.
- Recall date
- April 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)