Illumina Worklist Manager Software Recalled for Performance Failure
Illumina Inc is recalling 35 units of Illumina Worklist Manager software v1.0.15 because it fails to perform as intended.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software component that fails to perform as intended, posing a risk of harm without reported injuries, which aligns with the High severity criteria for risk-of-harm products.
Plain-English summary
Illumina Inc is recalling 35 units of Illumina Worklist Manager (IWM) software, version 1.0.15. This software is a component of the Illumina MiSeqDx Platform, a sequencing instrument intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.
The recall was initiated because the software fails to perform as intended. The affected units were distributed worldwide, including the United States, France, Germany, Italy, Norway, the United Kingdom, and the United Arab Emirates.
Users of the Illumina MiSeqDx Platform should check their software version and contact Illumina Inc for further instructions regarding the recall.
The recalled product
- Product
- Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow…
- Manufacturer
- Illumina Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 35
Distribution
Distributed nationwide across the United States.
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