medical MODERATE Updated 2023-06-28

Illumina, Inc. recalls NextSeq 550Dx Instrument, Catalog # 20005715, contaning Univ

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Recalled Product

NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software

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Hazard / Issue

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Impacted UCS Versions: 1.4.2.927, 1.6.3.1423, 2.7.2.4320/ UDI-DI: (00)816270020125

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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