The Recall Desk

Hazard

Patient Data Mixup 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
1
Most recent
2023-04-26

Of the 2 patient data mixup recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) 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 patient data mixup 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

  • HighFDA (Devices)·Z-1394-2023·2023-04-26

    Radiometer AQURE Software Recall Due to Patient Mix-up Risk

    Radiometer is recalling AQURE laboratory software versions 2.5.2 through 2.6.1 due to a potential issue that could cause patient data mix-ups.

    Product
    AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0864-2020·2020-02-05

    Radiometer AQURE basic system software recall for patient data mix-up risk

    Radiometer Medical ApS is recalling AQURE basic system software versions 2.3.5 and below due to a potential patient data mix-up risk when connected to third-party devices.

    Product
    AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
    Category
    Medical Device
    Distribution
    Distributed nationwide