Recall Z-0782-2024— Hologic, Inc.
Class II · Ongoing
Class II FDA medical device recall by Hologic, Inc., initiated 2023-12-15. FDA's recall record names no specific 510(k) clearance for this event. 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 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.. Reason: Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive..
- Recalling firm
- Hologic, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-15
- Firm location
- San Diego, CA, United States
Product description
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.
Reason for recall
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
Data sourced from openFDA. This site is unofficial and independent of the FDA.