Z-1592-2024Class II

Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

Name: Z-1592-2024 Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Creator: Actim Oy
Published: 2023-11-23
License: https://open.fda.gov/license/

Actim Oy / initiated 2023-11-23 / Open, Classified

FDA source

ACTIM OY began a recall of Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane on 2023-11-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1592-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-23
Posted: 2024-04-17
Recalling firm: Actim Oy
Product: Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Product code: OAM Immunoassay, Insulin-Like Growth Factor Binding Protein-1
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.
FDA root cause: Under Investigation by firm
Action: Actim Oy issued a MEDICAL DEVICE RECALL notice to its sole distributor on 11/23/2023 via email. The notice explained the issue, potential risk, and requested that users refrain from using surgical lubricants when collecting the vaginal specimen and that vaginal specimens do not contain significant amounts of personal lubricant from patient's recent personal use. The instructions for use will be updated according to the latest test results of surgical and personal lubricant interference. In the interim, a separate note will be included in the test kit regarding the correction of the interference claims and guidance of lubricant use.
Quantity in commerce: 6471 kits
Distribution: US Nationwide distribution in the state of Connecticut.
Product codes and lots: UDI/DI 06430030990608, All serial numbers in distribution

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1592-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1592-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-17

Product code OAM

K123986Class IActim PromAlere Scarborough, Inc. / cleared 2014-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)