Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Reported: April 24, 2024 Initiated: November 23, 2023 #Z-1592-2024
Product Description
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Reason for Recall
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.
Details
- Recalling Firm
- ACTIM OY
- Units Affected
- 6471 kits
- Distribution
- US Nationwide distribution in the state of Connecticut.
- Location
- Espoo
Frequently Asked Questions
What product was recalled? ▼
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane. Recalled by ACTIM OY. Units affected: 6471 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2024. Severity: Moderate. Recall number: Z-1592-2024.
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