medical MODERATE Updated 2022-04-06

Illumina, Inc. recalls Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

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Recalled Product

Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

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Hazard / Issue

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.

Issued by

FDA

Affected States: PA, WA, CA, MI, FL, MD, AR, UT, NC, IL, NE, NJ, TN, NY, IN, CO, GA, OK, TX, CT, SD, NM, VA, AL, LA, SC, WV, OR, IA, AZ, MN
Lot/Code Info: Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125

✅ 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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