Medical Device Recall: 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 thro
Hologic, Inc. · December 15, 2023
Reason for Recall
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
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.
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.
States Affected
NATIONWIDE
Quantity Affected
771 systems (of which 313 are potentially impacted)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0782-2024
Status: ongoing
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