Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Simplexa Flu A/B & RSV Direct Gen II Recalled by DiaSorin Molecular LLC Due to Direct amplification Discs , used with COVID-19 and...
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 Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
Quantity: 4142
Why Was This Recalled?
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
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