Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing recall: Software Issue
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Why was Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
- Product
- Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
- Recalling firm
- Illumina Inc
- Quantity
- 19 units
- Distribution
- US: MD, NY Non-US: France
- Recall date
- December 31, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)