Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Panther Fusion Extraction Reagent-X Recalled by Hologic, Inc Due to Failed stability specifications for reagent kits that may...
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 Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
Quantity: 264 kits
Why Was This Recalled?
Failed stability specifications for reagent kits that may result in false negative test results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hologic, Inc
Hologic, Inc has 24 total recalls tracked by RecallDetector.
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report