Reported Mar 15, 2023 · Ongoing

Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

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 COVID-19 Direct
REFMOL4150; including Reaction Mix
REF
- MOL4150
- with previous assay definition v2

Lot codes and dates: UDI-DI20816101027020
Product REF/Lot/Reaction Mix REF/Lot
MOL4150/US13950/MOL4151/US14091
MOL4150/US14913/MOL4151/US14063
MOL4150/US13952/MOL4151/US14065
MOL4150/US13955/MOL4151/US14086
MOL4150/US13959/MOL4151/US14088
MOL4150/US13956/MOL4151/US14087
MOL4150/US13960/MOL4151/US14093
MOL4150/US13961/MOL4151/US14094
MOL4150/US13973/MOL4151/US13732
MOL4150/US13974/MOL4151/US13736
MOL4150/US14006/MOL4151/US13738
MOL4150/US14004/MOL4151/US15064
MOL4150/US14005/MOL4151/US13737
MOL4150/US14008/MOL4151/US14100
MOL4150/US14007/MOL4151/US14099
MOL4150/US14010/MOL4151/US14102
MOL4150/US14011/MOL4151/US14103
MOL4150/US14012/MOL4151/US15290
MOL4150/US14018/MOL4151/US14111
MOL4150/US14009/MOL4151/US14101
MOL4150/US14017/MOL4151/US14109
MOL4150/15061N/MOL4151/13474N
MOL4150/X15475N/MOL4151/X15479N
MOL4150/13330N/MOL4151/14829N
MOL4150/13331N/MOL4151/13751N
MOL4150/13336N/MOL4151/13752N
MOL4150/13968N/MOL4151/14036N
MOL4150/14346N/MOL4151/14038N
MOL4150/13967N/MOL4151/15082N
Amount recalled: 90142

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Simplexa Flu A/B & RSV Direct Gen II

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.

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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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