Reported Mar 15, 2023 · Ongoing
Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition…
DiaSorin Molecular LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DiaSorin Molecular LLC · 11331 Valley View St · Cypress, CA · 90630-5366
Is this the product you have?
- Simplexa Flu A/B & RSV Direct Gen II
- REFMOL2655
- including Reaction Mix REF
MOL2656with previous assay definition v5
- Lot codes and dates
- UDI-DI20816101026962
- Product REF/Lot/Reaction Mix REF/Lot
MOL2655/13648N/MOL2656/13649NMOL2655/13882N/MOL2656/15164NMOL2655/15279N/MOL2656/15280N
- Amount recalled
- 4142
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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