Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Aptima CMV Quant Assay Recalled by Hologic, Inc. Due to Use of assay along with plasma specimen 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
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.
Quantity: 684 kits
Why Was This Recalled?
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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