Reported Jun 28, 2023 · Completed
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Illumina, Inc.
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: Illumina, Inc. · 5200 Illumina Way · San Diego, CA · 92122-4616
Is this the product you have?
- MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
- Lot codes and dates
- UCS VersionsUCS 2.5.0/
- UDI-DI(00)816270020002
- Amount recalled
- 740 units
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
- Nationwide
- GA
Why it was recalled
Cybersecurity vulnerability concerning the software used for sequencing instruments.
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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