The Recall Desk

Hazard

Reference Range Mismatch recalls

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

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2021-09-29

Of the 1 reference range mismatch 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 reference range mismatch 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.

1–1 of 1

  • HighFDA (Devices)·Z-2517-2021·2021-09-29

    Sight OLO-E1/U1 Reference Range Labeling Discrepancy in Software

    The Sight OLO-E1/U1 diagnostic device software contains a labeling discrepancy: the operator's manual and software present different adult CBC reference ranges, potentially affecting the interpretation of diagnostic results.

    Product
    Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
    Category
    Medical Device
    Distribution
    Distributed nationwide