Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Illumina MiSeqDx Universal Kit 1.0 Recalled by Illumina Inc Due to It was discovered a software limitation with MiSeq...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Illumina Inc directly.
Affected Products
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.
Quantity: 13 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 5 states: AZ, CA, GA, OH, VA
About Illumina Inc
Illumina Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report