The Recall Desk

Hazard

Inaccurate Blood Counts 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
2024-10-09

Of the 1 inaccurate blood counts 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 inaccurate blood counts 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-0009-2025·2024-10-09

    BD FACSDuet Sample Preparation System software defect causes inaccurate specimen volumes

    The BD FACSDuet sample preparation system may dispense specimen volumes that are 3% to 20% higher in one tube versus another, leading to inaccurate blood counts, delayed test results, and potential additional blood collection. The defect affects 130 systems distributed across the US and internationally.

    Product
    BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.
    Category
    Medical Device
    Distribution
    13 states