CLASS II Device recall · Reported 31 Dec 2014 · FDA Enforcement Report
MiSeqDx Universal Kit 0, PN 15039608 The Illumina MiSeqDx recalled
Illumina is recalling Illumina MiSeqDx Universal Kit 0, PN 15039608 The Illumina MiSeqDx Universal Kit 0 is a, distributed nationwide in the US. The recall was initiated on 13 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0849-2015
- FDA event ID
- 69766
- Recalling firm
- Illumina, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Nov 2014
- FDA classified
- 23 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Nov 2014 | Recall initiated by company | |
| 23 Dec 2014 | Classified by FDA | +40 days |
| 31 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
Questions about this recall
Is MiSeqDx Universal Kit 0, PN 15039608 The Illumina MiSeqDx Universal Kit 0 is a set of recalled?
Yes. Illumina recalled MiSeqDx Universal Kit 0, PN 15039608 The Illumina MiSeqDx Universal Kit 0 is a set of on 13 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0849-2015.
Why was it recalled?
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.
Which lots are affected?
Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.
Where was it sold?
US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Illumina
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Reagent Kits/ containing flow cells recalled by Illumina | Illumina | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | NextSeq 550Dx Instrument recalled by Illumina | Illumina | Device Malfunction | Nationwide |
| Device | CLASS II | MiSeq Dx Instrument recalled by Illumina | Illumina | Device Malfunction | Nationwide |
| Device | CLASS II | illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model recalled | Illumina | Other | Nationwide |
| Device | CLASS II | illumina Model NextSeq 550 Dx REF recalled | Illumina | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |