The Recall Desk

Hazard

Falsely Elevated Results recalls

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

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2025-07-30

Of the 4 falsely elevated results 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 falsely elevated results 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.

1–4 of 4

  • HighFDA (Devices)·Z-2152-2025·2025-07-30

    Estrone RIA kits give falsely increased results from a bovine albumin lot

    Estrone RIA kits are being recalled because a specific lot of bovine serum albumin used to manufacture the coated tubes caused falsely increased assay results. 496 units are affected.

    Product
    Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1455-2022·2022-08-03

    Abbott Alinity c Hemoglobin Reagent Kit may produce falsely elevated test results

    Abbott Laboratories is recalling the Alinity c Hemoglobin Reagent Kit because the ARCHITECT and Alinity c assays can generate falsely elevated Hemoglobin A1c results.

    Product
    REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-1023-2022·2022-05-11

    Medical Diagnostic Test Kit Issues Falsely Elevated Estradiol Results

    Siemens Healthcare is recalling ADVIA Centaur Enhanced Estradiol diagnostic kits because plasma specimens may show falsely elevated results, potentially leading clinicians to misinterpret patient test results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1020-2022·2022-05-11

    Estradiol diagnostic test kits recalled for falsely elevated results

    Siemens Atellica IM Enhanced Estradiol test kits can produce falsely elevated results in plasma specimens, potentially leading to misinterpretation of patient hormone measurements. Approximately 2,044 units worldwide are affected.

    Product
    Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide