The Recall Desk

Hazard

False Low Results recalls

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

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2024-12-04

Of the 7 false low 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 false low 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.

1–7 of 7

  • HighFDA (Devices)·Z-0535-2025·2024-12-04

    VITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results

    Ortho-Clinical Diagnostics is recalling 7,717 units of VITROS CRP diagnostic slides that may produce falsely low results for high C-reactive protein samples, risking missed diagnosis of infection or inflammation.

    Product
    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2079-2017·2017-05-24

    Beckman Coulter Recalls Uric Acid Reagent Due to Drug Interference

    Beckman Coulter is recalling Uric Acid Reagent because certain drugs can cause false low results. The recall covers 100,286 units distributed worldwide.

    Product
    Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2081-2017·2017-05-24

    Beckman Coulter Cholesterol Reagent Recalled for Potential Drug Interference

    Beckman Coulter is recalling Cholesterol Reagent (Catalog No. 467825) because specific drugs may cause false low results.

    Product
    Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2078-2017·2017-05-24

    Beckman Coulter Recalls Lactate Reagent Due to Interference from Specific Drugs

    Beckman Coulter is recalling Lactate Reagent (Catalog No. A95550) because certain drugs can cause false low results.

    Product
    Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2082-2017·2017-05-24

    Beckman Coulter Recalls HDL Cholesterol Reagent Due to Drug Interference

    Beckman Coulter is recalling HDL Cholesterol Reagent because specific drugs can cause false low results.

    Product
    HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1932-2016·2016-06-15

    Beckman Coulter Uric Acid Reagent Recalled for False Low Results

    Beckman Coulter is recalling Uric Acid reagent (OSR6x98) because Dipyrone may cause erroneous, false low results in assays.

    Product
    Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1930-2016·2016-06-15

    Beckman Coulter Lipase Reagent Recalled for Potential False Low Results

    Beckman Coulter is recalling Lipase OSR6x30 reagent because Dipyrone may cause erroneous false low results in lipase assays.

    Product
    Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide