Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic Recalled by Illumina Inc Due to Illumina has confirmed 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 Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Quantity: 19 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 2 states: MD, NY
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