The Recall Desk

Hazard

Reference Range Error 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
2022-08-03

Of the 1 reference range error 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 error 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-1469-2022·2022-08-03

    Hematology Analyzer Sight OLO Displays Incorrect Pediatric Reference Ranges

    The Sight OLO automated hematology analyzer displays mixed-up default reference ranges for children ages 2-11 in software versions 2.63, 2.63.1, and 2.63.1.1, which could cause test results to appear incorrectly normal or abnormal.

    Product
    Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
    Category
    Medical Device
    Distribution
    Distributed nationwide