Home / Recalls / Illumina Inc / Z-0850-2015

Z-0850-2015 Class III Terminated

Recalled by Illumina Inc — San Diego, CA

Recall Details

Product Type
Devices
Report Date
December 31, 2014
Initiation Date
November 6, 2014
Termination Date
March 17, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 units

Product Description

Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

Reason for Recall

Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.

Distribution Pattern

US: MD, NY Non-US: France

Code Information

Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.

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-0854-2022 Class II — Illumina NextSeq 550Dx, REF: 20005715, CE, IVD (February 22, 2022)
  • Z-0849-2015 Class II — Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universa (November 13, 2014)
  • Z-2611-2014 Class II — Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSe (July 28, 2014)