The Recall Desk

Hazard

Assay Accuracy 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
2025-06-04

Of the 2 assay accuracy 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 assay accuracy 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-1821-2025·2025-06-04

    Atellica IM Homocysteine Calibrator recalled for assay instability

    Siemens Healthcare Diagnostics is recalling certain lots of Atellica IM Homocysteine Calibrator because calibrator instability causes increased positive bias and does not meet the assay reference interval requirements.

    Product
    Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2024·2023-11-08

    RX Imola Clinical Chemistry Analyzer rerun feature may report results incorrectly

    RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.

    Product
    RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide