Hologic, Inc. recalls PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully au

Recalled January 31, 2024 · FDA recall Z-0782-2024 · Hologic

Hazard

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

Units

771 systems (of which 313 are potentially impacted)

Sold at

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.

Description

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

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.

Manufacturer(s)

Hologic, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →