Aptima®

Hologic, Inc. · Model KIT, ATV-V2, ROOM TEMP, 250T · UDI-DI 15420045505544

OUY Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Aptima® Trichomonas vaginalis Assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther® System.

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2019-07-17	Becton Dickinson & Co.	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

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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.