Recall Z-0850-2015— Illumina Inc
Class III · Terminated
Class III FDA medical device recall by Illumina Inc, initiated 2014-11-06, terminated 2015-03-17. It names one FDA 510(k) clearance: K132750. Product: Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.. Reason: 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..
- Recalling firm
- Illumina Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-11-06
- Terminated
- 2015-03-17
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.