The Recall Desk

Hazard

Software Limitation recalls

2 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2014-12-31

Of the 2 software limitation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software limitation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–2 of 2

  • ModerateFDA (Devices)·Z-0849-2015·2014-12-31

    Illumina MiSeqDx Universal Kit 1.0 Recalled for Software Limitation

    Illumina Inc is recalling 13 units of the MiSeqDx Universal Kit 1.0 because a software limitation prevents the reporting of specific genomic insertions and deletions.

    Product
    Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sampl
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-0850-2015·2014-12-31

    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.

    Product
    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
    Category
    Medical Device
    Distribution
    2 states