Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Summary
The FDA issued a Class II for Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for ruptur by ACTIM OY. Reason: Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a.
Details
Source
Device Recall
External ID
Z-1592-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
Product Description
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Lot/Code Info: UDI/DI 06430030990608, All serial numbers in distribution
Quantity Affected: 6471 kits
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.
Distribution
US Nationwide distribution in the state of Connecticut.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-23
Company
Espoo
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ACTIM OY) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ACTIM OY have FDA actions?
This is the only FDA action we have on record for ACTIM OY in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1592-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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