Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SIMPLEXA COVID-19 Positive Control Pack Recalled by DiaSorin Molecular LLC Due to Due to unapproved raw materials used in the...
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 COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Quantity: 1690 kits
Why Was This Recalled?
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
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