Hologic PANTHER FUSION System Recalled for Potential False Positive Flu B Results
Hologic is recalling PANTHER FUSION nucleic acid testing systems due to the potential for false positive influenza B test results when a sample is also positive for SARS-CoV-2.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The hazard is theoretical—a potential false positive diagnostic result that could lead to incorrect clinical decision-making. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Hologic, Inc. is recalling 771 PANTHER FUSION System nucleic acid testing devices (313 potentially impacted by this issue). The PANTHER Fusion System is an integrated, fully automated in vitro diagnostic clinical multiplex test system used for nucleic acid-based testing from sample processing through amplification, detection, and data reduction.
The recall is due to the potential for false positive influenza B test results when a sample is also positive for SARS-CoV-2. This diagnostic error could lead to incorrect test interpretation and inappropriate clinical decisions.
These systems have been distributed worldwide, including throughout the United States, Puerto Rico, U.S. Virgin Islands, and to multiple countries including Austria, Australia, Belgium, the Dominican Republic, France, Germany, Great Britain, Hong Kong, Ireland, Italy, South Korea, Kuwait, the Netherlands, New Zealand, Norway, Portugal, Qatar, Spain, Sweden, and Switzerland.
Facilities using affected PANTHER FUSION systems should contact Hologic for instructions on corrective actions. Users should review their testing procedures and consider the potential for false positive Flu B results in patients with concurrent SARS-CoV-2 infection.
The recalled product
- Product
- PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is…
- Manufacturer
- Hologic, Inc.
Distribution
Related recalls
Same manufacturer · Hologic, Inc.
See all →- SevereHologic Selenia Dimensions Mammography Systems Loose Internal Bolts
FDA (Devices) · 2026-05-20
- ModerateHologic 3DIMENSIONS MAMMOGRAPHY SYSTEM medical device recall
FDA (Devices) · 2026-05-20
- ModerateGenius Review Station Display Modified Outside Validated Configuration
FDA (Devices) · 2026-05-06
- HighHologic Aptima HPV assay may produce invalid or false negative results
FDA (Devices) · 2026-03-25
- HighBreast biopsy needles recalled over particulates that can enter tissue
FDA (Devices) · 2026-02-18
Same hazard · false positive
See all →- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighpTau 217 plasma calibrators recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
Similar recalls
- HighHologic Panther Fusion Recalled Due to Falling Glass Panel Hazard
FDA (Devices) · 2018-02-21
- HighHologic Panther Fusion Extraction Reagent-S Recalled for False Test Results
FDA (Devices) · 2020-06-03
- HighPanther Fusion Assay Kit Recalled for Possible SARS-CoV-2 False Positives
FDA (Devices) · 2025-01-01
- HighHologic Recalls Panther Fusion Tube Trays Due to Potential Leaks
FDA (Devices) · 2020-09-30
- HighPanther Fusion GBS Assay Cartridges Recalled for False Negative Results
FDA (Devices) · 2022-04-13
- HighHologic Recalls Panther Fusion Tube Trays Due to Potential Leakage
FDA (Devices) · 2021-04-14