Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Recalled by DiaSorin Molecular LLC Due to Due to a software malfunction in the Multi...
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
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.
Quantity: 13943 plastic vials (24 vials per box)
Why Was This Recalled?
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
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