Z-0849-2015Class II

Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents...

Name: Z-0849-2015 Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents...
Creator: Illumina Inc
Published: 2014-11-13
License: https://open.fda.gov/license/

Illumina, Inc. / initiated 2014-11-13 / Terminated / root cause: software

FDA source

Illumina Inc began a recall of Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human... on 2014-11-13. FDA classified it as Class II and gives the reason as "It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific...". 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-0849-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-13
Posted: 2014-12-23
Terminated: 2015-03-18
Recalling firm: Illumina, Inc.
Product: Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.
Product code: PFS System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
Reason for recall: It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer.
Root cause tag: software
FDA root cause: Software design
Action: A customer letter dated November 13, 2014, was sent to all customers who is using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The letter informs the customers that Illumina has recently confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer. The customer notification outlines the potential issues, the results of investigation, actions required, and next steps. Customers are instructed to return the attached Verification form to confirm their receipt of the letter and document the results of any patient impact from the limitation. 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]. For further questions, please call (858) 736-3861.
Quantity in commerce: 13 units
Distribution: US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
Product codes and lots: Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0849-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0849-2015	Class II	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)