Illumina MiSeqDx Universal Kit 1.0 recall: Software Issue
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…
Why was Illumina MiSeqDx Universal Kit 1.0 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.
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?
Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.
- 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…
- Recalling firm
- Illumina Inc
- Quantity
- 13 units
- Distribution
- US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
- Recall date
- December 31, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)