Z-0850-2015Class III

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

Name: Z-0850-2015 Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina...
Creator: Illumina Inc
Published: 2014-11-06
License: https://open.fda.gov/license/

Illumina, Inc. / initiated 2014-11-06 / Terminated / root cause: software

FDA source

Illumina Inc began a recall of Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform on 2014-11-06. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0850-2015
Classification: Class III
Status: Terminated
Initiated: 2014-11-06
Posted: 2014-12-23
Terminated: 2015-03-17
Recalling firm: Illumina, Inc.
Product: Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Product code: PFS System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: A customer notification letter dated 11/12/14 was sent to all customers who purchased the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay. The letter confirms that there is a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument. At certain genomic locations within the region sequenced by the assay, deletions cannot be reported by the software. The letter outlines the potential issues, the results of Illuminia's investigation, and the firm's next steps. Customers' with technical questions or concerns, are instructed to contact their local support team or Illumina Technical Support at [email protected]. Customers with questions regarding the field action, are instructed to contact Illumina Regulatory Affairs at [email protected]. Customers will be contacted by 11/13/14 by phone and a phone script was provided that includes the procedure, talking points, actions required, and next steps.
Quantity in commerce: 19 units
Distribution: US: MD, NY Non-US: France
Product codes and lots: Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0850-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0850-2015	Class III	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23

Product code PFS

K132750Class IIIllumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayIllumina, Inc. / cleared 2013-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)