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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.