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.
What this means for you
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 a
- Manufacturer
- Hologic, Inc.
- Hazard
- false-positive
- diagnostic-error
Distribution
Distributed nationwide across the United States.
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