Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0849-2015·Announced 2014-12-31

Illumina MiSeqDx Universal Kit 1.0 Recalled for Software Limitation

Illumina Inc is recalling 13 units of the MiSeqDx Universal Kit 1.0 because a software limitation prevents the reporting of specific genomic insertions and deletions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no hospitalizations or serious injuries are reported. The hazard is a software limitation affecting data reporting rather than a direct physical safety risk.

Plain-English summary

Illumina Inc is recalling 13 units of the Illumina MiSeqDx Universal Kit 1.0, Part Number 15039608. This product is a set of reagents and consumables used to process human genomic DNA samples from peripheral whole blood for targeted sequencing on the MiSeqDx instrument.

The recall was initiated due to a discovered software limitation in the MiSeq Reporter software (version 2.2.31). When using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument, the software is unable to report insertions or deletions at specific genomic locations with respect to the primer.

The affected units were distributed in the United States to the states of Arizona, Georgia, California, Ohio, and Virginia, as well as internationally to France. The specific serial numbers for the recalled units are M70130, M70189, M70108, M70165, M70166, M70175, M70172, and M70103. Users should contact Illumina Inc for further instructions on how to proceed.

The recalled product

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…
Manufacturer: Illumina Inc
Category: Medical Device — In Vitro Diagnostic
Hazard: software-limitation
data-integrity
Affected units: 13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

Serial No. M70130
M70189
M70108
M70165
M70166
M70175
M70172
M70103.

Distribution

Distributed in 5 states:

Same manufacturer · Illumina Inc

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Same hazard · software limitation