The Recall Desk

Hazard

Assay Inaccuracy recalls

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

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2024-03-20

Of the 3 assay inaccuracy 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 inaccuracy 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.

1–3 of 3

  • HighFDA (Devices)·Z-1280-2024·2024-03-20

    Siemens Atellica IM Erythropoietin assay recalled for calibration bias error

    Siemens has recalled the Atellica IM Erythropoietin assay due to a 35% negative bias compared to WHO standards. The assay does not achieve claimed reference intervals and could report inaccurate test results.

    Product
    Atellica IM Erythropoietin (EPO) Assay (100 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2019·2019-08-21

    Luminex ARIES GBS Assay Recalled for Partially Sealed Side Cassettes

    Luminex Corporation is recalling ARIES GBS Assay kits because partially sealed side cassettes may cause decreased assay sensitivity or stability.

    Product
    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2288-2019·2019-08-21

    Luminex ARIES Extraction Kit Recalled for Partially Sealed Cassette Assemblies

    Luminex Corporation is recalling ARIES Extraction Kits because partially sealed side cassette assemblies may reduce assay sensitivity and stability.

    Product
    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
    Category
    Medical Device
    Distribution
    34 states