Illumina Inc: Medical Device Recall in 2014 - (Recall #: Z-0850-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: November 6, 2014

Date Posted: December 31, 2014

Recall Number: Z-0850-2015

Event ID: 69715

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.

Status: Terminated

Product Quantity: 19 units

Code Information:

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

Distribution Pattern:

US: MD, NY Non-US: France

Voluntary or Mandated:

Voluntary: Firm initiated