The Recall Desk

Hazard

Inaccurate Results recalls

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

What the numbers show

Total
469
Critical
0
Severe
6
Most recent
2026-09-02

Of the 469 inaccurate 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 6 (1%) 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 inaccurate 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.

201–225 of 469

  • HighFDA (Devices)·Z-2081-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK FT4 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2018·2018-06-13

    Tosoh ST-AIA PACK Cort Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Cort assays because the drug Strensiq interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2088-2018·2018-06-13

    Tosoh Estradiol Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK Estradiol assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2018·2018-06-13

    Tosoh Myoglobin Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK Myoglobin assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2018·2018-06-13

    Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc. is recalling ST-AIA PACK 27.29 tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2018·2018-06-13

    Tosoh ST-AIA PACK AFP Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK AFP assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2018·2018-06-13

    Tosoh ST-AIA PACK Cystatin C Assay Recalled Due to Drug Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Cystatin C assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2018·2018-06-13

    Tosoh ST-AIA C-Peptide II Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK C-Peptide II assays because the drug Asfotase Alfa can cause inaccurate test results.

    Product
    ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2018·2018-06-13

    Tosoh ST-AIA PACK IRI Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK IRI assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2018·2018-06-13

    Tosoh ST-AIA DHEA-S Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA DHEA-S assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2080-2018·2018-06-13

    Tosoh ST-AIA PACK FT3 Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK FT3 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate thyroid results.

    Product
    ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2079-2018·2018-06-13

    Tosoh ST-AIA PACK T4 Thyroid Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK T4 thyroid assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2018·2018-06-13

    Tosoh ST-AIA PACK Prog II Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Prog II assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2018·2018-05-23

    Beckman Coulter Recalls MicroScan MICroSTREP Plus Panel Due to QC Failures

    Beckman Coulter is recalling 523 boxes of MicroScan MICroSTREP Plus Panel and associated broth due to quality control testing failures.

    Product
    BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. MICroSTREP plus p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1662-2018·2018-05-16

    Siemens Syva Emit 2000 Sirolimus Assay Recalled for Interference

    Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Sirolimus Assay because it may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.

    Product
    Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1661-2018·2018-05-16

    Siemens Tacrolimus Assay Recalled for Interference with Sulfasalazine and Sulfapyridine

    Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Tacrolimus Assay because it may produce inaccurate results when patients take sulfasalazine or sulfapyridine.

    Product
    Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1655-2018·2018-05-16

    Siemens Dimension Vista Ammonia Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Ammonia assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1650-2018·2018-05-16

    Siemens Dimension ALTI Assay Recalled for Drug Interference

    Siemens is recalling Dimension ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.

    Product
    Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1652-2018·2018-05-16

    Siemens Dimension Glucose Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Glucose assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1629-2018·2018-05-16

    Abbott ARCHITECT DHEA-S Reagent Recalled for False Infant Results

    Abbott is recalling ARCHITECT DHEA-S Reagent because it may produce falsely elevated results when used on samples from infants up to 60 days old.

    Product
    ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Devices)·Z-1658-2018·2018-05-16

    Siemens Dimension Vista Glucose Assay Recalled for Drug Interference

    Siemens is recalling Dimension Vista Glucose assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1689-2018·2018-05-16

    Siemens ADVIA Centaur Folate Recalled for Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate assays because biotin interference levels are not listed in the instructions, potentially affecting test accuracy.

    Product
    ADVIA Centaur¿ Folate (FOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1649-2018·2018-05-16

    Siemens Dimension Ammonia Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Ammonia assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1651-2018·2018-05-16

    Siemens Dimension AST Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension AST assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states