CLASS III Device recall · Reported 31 Dec 2014 · FDA Enforcement Report
MiSeqDx Cystic Fibrosis Clinical Sequencing Assay recalled by Illumina
Illumina is recalling MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on, distributed in Maryland, New York. The recall was initiated on 6 Nov 2014 and the FDA has classified it as Class III.
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-0850-2015
- FDA event ID
- 69715
- Recalling firm
- Illumina, San Diego, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Nov 2014
- FDA classified
- 23 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Nov 2014 | Recall initiated by company | |
| 23 Dec 2014 | Classified by FDA | +47 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
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Where it was distributed
US: MD, NY Non-US: France
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
Where was it sold?
US: MD, NY Non-US: 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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