FDAFDA · Food and drugs·Recall number Z-0850-2015
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Published December 31, 2014 · Recall initiated: November 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Illumina Inc
- Distributor
- US: MD, NY Non-US: France
- Lot
- Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.