Illumina MiSeqDx Cystic Fibrosis Assay Recalled for Software Limitation
Illumina is recalling 19 units of the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay due to a confirmed software limitation in version 2.2.31.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences, and the source text does not report any illnesses or injuries.
Plain-English summary
Illumina Inc is recalling 19 units of the Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay. This in vitro diagnostic system is designed for use on the Illumina MiSeqDx Platform.
The recall was initiated because Illumina confirmed a software limitation with MiSeq Reporter software, version 2.2.31, when used with the Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument. The affected units are associated with instrument serial numbers M70106, M00533L, and M70114, and shipped lot numbers K103313, K103461, K103404, and K103487.
The affected products were distributed in Maryland and New York in the United States, as well as in France. The source text does not specify the actions consumers or healthcare providers should take in response to this recall.
The recalled product
- Product
- Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
- Manufacturer
- Illumina Inc
- Hazard
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Instrument Serial No. M70106
- M00533L
- M70114. Lot No. Shipped: K103313
- K103461
- K103404
- K103487.
Distribution
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