FDA-Device2025-01-22Class II
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Hologic, Inc.
Hazard
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Sold states
AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
Affected count
380
Manufactured in
10210 Genetic Center Dr, San Diego, CA, United States
Products
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0907-2025Don't want to check this manually?
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