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Actim PROM Controls

Actim Oy · Model 30800ETUS · UDI-DI 06430030990622

OAM Prescription
1
510(k) clearances
7
Adverse events
1
Recalls
12
Facilities

Description

The Actim PROM Controls kit consists of one of each of the following components: 1. Actim PROM Negative Control (0 μg/L) 2. Actim PROM Low Positive Control (40 μg/L) 3. Actim PROM High Positive Control (250 μg/L) 4. Actim Reconstitution Solution 5. Instructions for use

Recalls

DateFirmReason
2023-11-23ACTIM OYInterference 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.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.