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Recall Observatory FDA recall evidence

Device product

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

Z-0850-2015

November 06, 2014

Class III

Product summary

Firm
Illumina Inc
Event
Event 69715
Status
Terminated
Classification
Class III
Quantity
19 units
Official record key
device-enforcement:Z-0850-2015

Official wording

Reason: 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.

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

Distribution pattern: US: MD, NY Non-US: France

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.