FDA recall Z-0782-2024

Hologic, Inc. · Class II · device

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 for recall

Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.

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.

Key facts

Status
Ongoing
Initiation date
2023-12-15
Report date
2024-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0782-2024