Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion Recalled by Hologic, Inc. Due to Potential weak pouch seal on Panther Fusion GBS...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc. directly.
Affected Products
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Quantity: 380
Why Was This Recalled?
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Where Was This Sold?
This product was distributed to 19 states: AR, CA, CT, FL, IN, KS, LA, ME, MA, MI, NV, NJ, NY, NC, TX, UT, VT, WA, WV
About Hologic, Inc.
Hologic, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report