Z-2611-2014Class II

Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform

Name: Z-2611-2014 Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform
Creator: Illumina Inc
Published: 2014-07-28
License: https://open.fda.gov/license/

Illumina, Inc. / initiated 2014-07-28 / Terminated / root cause: design

FDA source

Illumina Inc began a recall of Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument... on 2014-07-28. FDA classified it as Class II and gives the reason as "A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2611-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-28
Posted: 2014-09-09
Terminated: 2014-11-12
Recalling firm: Illumina, Inc.
Product: Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.
Product code: PFF High Throughput Dna Sequence Analyzer
Reason for recall: A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
Root cause tag: design
FDA root cause: Device Design
Action: Illumina notified affected customers via phone, email and Product Quality Notification letter dated July 28, 2014 to describe the software anomaly. The letter identified the affected product, problem and actions to be taken. For questions contact your local support team or Illumina Technical Support at [email protected].
Quantity in commerce: 35
Distribution: Worldwide Distribution - US (nationwide) and the countries of: France, Germany, Italy, Norway, UK and United Arab Emirates.
Product codes and lots: M70113 M70144 M70131 M70138 M70143 M70119 M70134 M70156 M70103 M70123 M70159 M70153 M70136 M70102 M70137 M70130 M00533L M70139 M70132 M70160 M70106 M70135 M70107 M70104 M70108 M70157 M70105 M70165 M70116 M70172 M70166 M70114 M70158 M70109 M70115

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2611-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2611-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08

Product code PFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)