Aptima® KIT, MAIN ASSAY, CMV, 100-TEST, IVDRecalls & reported problems

Hologic, Inc. · 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. · Class 2

All models of Aptima (15)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15420045514553), received between Jun 15, 2023 and Mar 11, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Sep 14, 2023Class IIOpen, Classified
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Z-1371-2024 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Device problems

Insufficient Device Problem Information1
No Apparent Adverse Event1
Unable to Obtain Readings1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryMar 11, 2024Unable to Obtain Readings; Unable to Obtain Readings
FOLLOW-UP REPORT. SEE SECTION H10.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18882728 ↗
InjuryJun 15, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
FOLLOW-UP REPORT. SEE SECTION H10.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17140554 ↗

Device details

UDI-DI	`15420045514553`
Brand	Aptima®
Model	KIT, MAIN ASSAY, CMV, 100-TEST, IVD
Catalog no.	ASY-12071
Company	Hologic, Inc.
Product code	PAB · Cytomegalovirus (cmv) dna quantitative assay
Class	Class 2
FDA submission	K243935
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 3, 2025

Device type (GMDN): Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from cytomegalovirus (CMV) in a clinical specimen, using a nucleic acid technique (NAT).

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page