Aptima®

Hologic, Inc. · Model KIT, MAIN ASSAY, CMV, 100-TEST, IVD · UDI-DI 15420045514553

PAB Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Aptima® CMV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma on the fully automated Panther® system.

Recalls

Date	Firm	Reason
2023-09-14	Hologic, Inc.	Use of assay along with plasma specimen may result in error code which would invalidate sample.

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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.