Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PANTHER FUSION System REF 9121010000 The Panther System is an Recalled by Hologic, Inc. Due to Due to potential false positive Flu B results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc. directly.
Affected Products
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 an integrated, fully automated, in vitro diagnostic (IVD) clinical multiplex test system. It is capable of performing nucleic acid based tests from sample processing through amplification, detection, and data reduction.
Quantity: 771 systems (of which 313 are potentially impacted)
Why Was This Recalled?
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hologic, Inc.
Hologic, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report