Home / Recalls / Illumina, Inc. / Z-0854-2022

Z-0854-2022 Class II

Recalled by Illumina, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
April 6, 2022
Initiation Date
February 22, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
674 instruments

Product Description

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

Reason for Recall

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.

Distribution Pattern

US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK, TX, CT, SD, NM, VA, AL, LA, SC, WV, OR, IA, AZ, MN OUS: Australia Austria Belgium Chile China Denmark Finland France Germany Hungary Ireland Italy Japan Latvia Netherlands Norway Poland Portugal Romania Russian Federation Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom Vietnam

Code Information

Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125

Other recalls by Illumina, Inc.

  • Z-0884-2026 Class II — Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: Ne (October 28, 2025)
  • Z-1977-2023 Class II — MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) s (April 5, 2023)
  • Z-1976-2023 Class II — NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service s (April 5, 2023)
  • Z-1260-2022 Class II — illumina Model NextSeq 550 Dx REF 20005715 (May 3, 2022)
  • Z-1259-2022 Class II — illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq D (May 3, 2022)
  • Z-0849-2015 Class II — Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universa (November 13, 2014)
  • Z-0850-2015 Class III — Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic (November 6, 2014)
  • Z-2611-2014 Class II — Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSe (July 28, 2014)