Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Simplexa Direct Amplification Disc Kit Recalled by DiaSorin Molecular LLC Due to There is a potential for the direct amplification...
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 DiaSorin Molecular LLC directly.
Affected Products
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
Quantity: 4,7878 units
Why Was This Recalled?
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About DiaSorin Molecular LLC
DiaSorin Molecular LLC has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report