Reported Apr 6, 2022 · Completed
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
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?
- Illumina NextSeq 550Dx
- REF20005715, CE, IVD
- Lot codes and dates
- Lot #s NDX550110 - NDX550843
- UDI(01)00816270020125
- Amount recalled
- 674 instruments
Where it was sold
Why it was recalled
There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.
This product could cause temporary or reversible health problems — stop using it.
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