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Open, Classified

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

FDA Recall Z-1592-2024 · Posted 2024-04-17

Recalling FirmACTIM OY
Recall StatusOpen, Classified
Product CodeOAM
Date Initiated2023-11-23
Product Quantity6471 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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the state of Connecticut.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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