PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: January 31, 2024 Initiated: December 15, 2023 #Z-0782-2024

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.

Details

Recalling Firm
Hologic, Inc.
Units Affected
771 systems (of which 313 are potentially impacted)
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AK, AR, CA, CO, CT, FL, IL, IN, MA, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NM, NV, NY, OH, PA, Puerto Rico, TX, UT, VA, VI, WA, WI, and WV. The countries of Austria, Australia, Belgium, Dominican Republic, Switzerland, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Ireland, Italy, Korea, Kuwait, The Netherlands, Norway, New Zealand, Portugal, Qatar, and Sweden.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Hologic, Inc.. Units affected: 771 systems (of which 313 are potentially impacted).
Why was this product recalled?
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 31, 2024. Severity: Moderate. Recall number: Z-0782-2024.