FDA Medical Device Recalls (openFDA)
Illumina Inc: Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
- Recall number
- Z-0850-2015
- Recalling firm
- Illumina Inc
- Product
- Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
- Status
- Terminated
- Initiated
- 2014-11-06
- Posted
- 2014-12-23
- Terminated
- 2015-03-17
- 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.
- Root cause
- Under Investigation by firm
- Action
- A customer notification letter dated 11/12/14 was sent to all customers who purchased the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay. The letter confirms that there is a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument. At certain genomic locations within the region sequenced by the assay, deletions cannot be reported by the software. The letter outlines the potential issues, the results of Illuminia's investigation, and the firm's next steps. Customers' with technical questions or concerns, are instructed to contact their local support team or Illumina Technical Support at techsupport@illumina.com. Customers with questions regarding the field action, are instructed to contact Illumina Regulatory Affairs at RA@illumina.com. Customers will be contacted by 11/13/14 by phone and a phone script was provided that includes the procedure, talking points, actions required, and next steps.
- Quantity
- 19 units
- Distribution
- US: MD, NY Non-US: France
- Lot, serial or model codes
- Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
- 510(k) numbers
- ["K132750"]
- PMA numbers
- not on file
- Product code
- PFS
- Firm FEI
- 3003218906
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28