Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Panther Fusion Extraction Reagent-S Recalled by Hologic, Inc Due to Reagent component included in flu test kit 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-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214
Quantity: 47 kits
Why Was This Recalled?
Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.
Where Was This Sold?
This product was distributed to 14 states: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, WA, WI
About Hologic, Inc
Hologic, Inc has 24 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report