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.

176–200 of 469

  • ModerateFDA (Devices)·Z-0676-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK ACTH In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling 1,085 units of ST AIA-PACK ACTH in vitro diagnostic reagents distributed nationwide in the US.

    Product
    ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain dis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0615-2019·2018-12-26

    Abbott i-STAT CG8+ Cartridges Recalled for Inaccurate Potassium Results

    Abbott Point Of Care Inc. is recalling i-STAT CG8+ Cartridges because they may generate inaccurate potassium results, potentially leading to incorrect clinical decisions.

    Product
    Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0611-2019·2018-12-26

    Diagnostica Stago Recalls Staclot LA 20 Test Kits Due to Result Variability

    Diagnostica Stago is recalling Staclot LA 20 test kits because some results showed shortened times outside the expected range.

    Product
    Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0604-2019·2018-12-19

    Binding Site Human IgM Kit Recalled for Calibration Curve Validation Issues

    The Binding Site Group is recalling 60 units of Human IgM Kits due to challenges in validating the calibration curve, indicated by control values outside specified ranges.

    Product
    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative an
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0561-2019·2018-12-12

    Helena Laboratories Recalls Cascade Abrazo c-ACT-LR Test Cards

    Helena Laboratories is recalling 27 kits of Cascade Abrazo c-ACT-LR Test Cards due to reported variations in test results.

    Product
    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0475-2019·2018-11-28

    Tosoh AIA-2000 Analyzer Recall Due to Potential Wash Solution Defect

    Tosoh Bioscience is recalling seven AIA-2000 analyzers because a liquid suction pump defect may cause incomplete washing, leading to inaccurate test results.

    Product
    AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0476-2019·2018-11-28

    Ortho-Clinical VITROS dLDL Reagent Recalled for Negatively Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products dLDL Reagent GENs 26 and 27 because the in vitro diagnostic may produce negatively biased results.

    Product
    VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0477-2019·2018-11-28

    Binding Site Human IgM Kit Recalled for Reduced Accuracy

    The Binding Site Group is recalling 108 units of Human IgM Kits due to reduced accuracy in control results and potential out-of-range readings.

    Product
    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative an
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0494-2019·2018-11-28

    BD Vacutainer Urine Cup Kit Recall for Potential RBC Count Elevation

    Becton Dickinson is recalling BD Vacutainer Urine Cup Kits because they may cause slight red blood cell count elevations when used with specific analyzers.

    Product
    KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0491-2019·2018-11-28

    BD Vacutainer Urine Collection Cups Recalled for Potential RBC Count Elevation

    Becton Dickinson is recalling BD Vacutainer Urine Collection Cups because they may cause slight elevations in red blood cell counts when used with specific analyzers.

    Product
    BD Vacutainer Urine Collection Cups, Cat. No. 364941
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0466-2019·2018-11-21

    Siemens Dimension Vista Lipase Reagent Cartridge Recalled for Variability

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Lipase Flex Reagent Cartridges due to lot-to-lot variability in quality control and patient results.

    Product
    Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2019·2018-10-24

    Siemens Atellica IM CKMB Master Curve Material Recalled for Potential Bias

    Siemens Healthcare Diagnostics is recalling Atellica IM CKMB Master Curve Material due to a potential bias identified when compared to internal standards.

    Product
    Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0080-2019·2018-10-17

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems

    Ortho-Clinical Diagnostics is recalling refurbished VITROS 5600 Integrated Systems because they may dispense insufficient sample volumes without suppressing potentially incorrect results.

    Product
    VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0060-2019·2018-10-10

    Ortho VITROS Prolactin Reagent Pack Recalled for Biotin Interference

    Ortho Clinical Diagnostics is recalling VITROS Prolactin Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.

    Product
    VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2923-2018·2018-09-05

    Tecan Recalls Cortisol Saliva Luminescence Immunoassay Kits for Inaccurate Results

    Tecan US, Inc. is recalling specific lots of the IBL International Cortisol Saliva Luminescence Immunoassay because the product generates cortisol values 1.3 to 1.8 times higher than the NIST standard.

    Product
    Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. Th
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2953-2018·2018-09-05

    Sysmex Fluorocell PLT Reagent Recalled for Inaccurate Platelet Counts

    Sysmex America is recalling Fluorocell PLT reagent because it may cause falsely low platelet and immature platelet fraction results.

    Product
    Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2437-2018·2018-07-25

    Siemens Dimension Vista MULTI 1 SDIL Diluent Recall for Defective Septum

    Siemens is recalling 197 units of Dimension Vista MULTI 1 SDIL diluent due to a potential defect in the vial cap septum that may cause inaccurate test results.

    Product
    Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2286-2018·2018-07-04

    Horiba Medical Recalls ABX Pentra Micro Albumin Reagents Due to Result Elevation

    Horiba Medical is recalling ABX Pentra Micro Albumin 2 CP reagents because they may produce elevated results if used immediately after a specific creatinine reagent.

    Product
    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2182-2018·2018-06-20

    Siemens Gentamicin Reagent Cartridge Recall Due to Low-End Inaccuracy

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Gentamicin Flex reagent cartridges because they may produce inaccurate results at low concentrations.

    Product
    Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2018·2018-06-20

    Siemens Recalls Dimension Gentamicin Flex Reagent Cartridges Due to Inaccuracy

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Gentamicin Flex reagent cartridges because they may produce inaccurate test results at the low end of the measurement range.

    Product
    Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2018·2018-06-13

    Tosoh C-Peptide Assay Recalled Due to Strensiq Interference

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

    Product
    ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2018·2018-06-13

    Tosoh AIA-PACK TSH 3rd Generation Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling AIA-PACK TSH 3rd Generation assays because Asfotase Alfa interferes with the tests, potentially causing inaccurate results.

    Product
    AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
    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
  • 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-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