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.

276–300 of 469

  • ModerateFDA (Devices)·Z-1071-2017·2017-02-01

    Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.

    Product
    Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ai
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1073-2017·2017-02-01

    Binding Site IgG4 Kit Recalled for Inaccurate Results in High Levels

    The Binding Site Group is recalling MininephThl Human IgG4 Kits because samples with extremely high IgG4 levels may yield spuriously low results.

    Product
    MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1053-2017·2017-01-25

    Freelite Human Lambda Free Kit Recalled for Calibration Curve Error

    The Binding Site Group is recalling Freelite Human Lambda Free Kits due to a calibration curve change that causes an increase in false prozone flags.

    Product
    Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1043-2017·2017-01-25

    Optilite Freelite Lambda Free Kit Recalled for Inaccurate Test Results

    The Binding Site Group is recalling 809 Optilite Freelite Lambda Free Kits because specific lots produce test results that are approximately 33% lower than expected.

    Product
    Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0903-2017·2017-01-04

    Ortho-Clinical Diagnostics Recalls VITROS Intact PTH Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to a positive bias of up to 20% and an incorrectly set reference interval.

    Product
    VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2017·2016-12-28

    Siemens IMMULITE 2000 PSA Assay Recalled for Hook Effect Performance Issues

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 PSA assays because they do not meet the High-dose Hook Effect expectations stated in the Instructions for Use.

    Product
    IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0762-2017·2016-12-21

    Randox Liquid Cardiac Controls Recalled for Decreased Analyte Recovery

    Randox Laboratories is recalling Randox Liquid Cardiac Controls Level 1, 2, and 3 because internal stability monitoring revealed decreased recovery of myoglobin and CKMB.

    Product
    The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Di
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0652-2017·2016-11-30

    Siemens Dimension Vista Chemistry 1 Calibrator Recall for Low Calcium Recovery

    Siemens is recalling Dimension Vista Chemistry 1 Calibrators (lots 5GM081 and 5GM082) because they may cause discrepant low calcium recovery in quality control and patient samples.

    Product
    Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2017·2016-11-23

    Siemens Vitamin D Total Assay Recalled for Plasma Sample Bias

    Siemens Healthcare Diagnostics is recalling Vitamin D Total Assay kits due to a negative bias when testing plasma samples instead of serum.

    Product
    Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2017·2016-11-23

    Roche Tina-Quant Hemoglobin A1c Test Recalled for Erroneously High Results

    Roche Diagnostics is recalling Tina-Quant Hemoglobin A1c Gen. 2 tests because they may produce erroneously high results, potentially leading to incorrect diabetes treatment.

    Product
    Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0397-2017·2016-11-23

    Siemens Vitamin D Total Assay Recalled for Specimen Correlation Issues

    Siemens Healthcare Diagnostics is recalling Vitamin D Total Assay kits due to a negative bias in plasma samples compared to serum samples.

    Product
    Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0123-2017·2016-10-26

    Randox Lipase Test System Recalled for Carryover Interference

    Randox Laboratories is recalling 18 units of Lipase test kits due to carryover interference when run near LDL or Triglycerides assays.

    Product
    Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2017·2016-10-12

    Siemens Dimension Vista Calcium Reagent Cartridge Recall for Erroneous Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Calcium reagent cartridges that may produce inaccurate test results.

    Product
    Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0008-2017·2016-10-12

    Microgenics Recalls QMS Everolimus Assay Due to Reagent Stability Issue

    Microgenics Corporation is recalling the Thermo Scientific QMS Everolimus Assay because a reagent stability issue causes inaccurate test results for transplant patients.

    Product
    Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2887-2016·2016-10-05

    R&D Systems Recalls Quantikine IVD sTfR Immunoassay Kits Due to Control Issues

    R&D Systems is recalling 725 Quantikine IVD sTfR Immunoassay Kits because internal testing confirmed that control results were out of range high.

    Product
    R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2884-2016·2016-10-05

    Microgenics Recalls DRI Salicylate Serum Tox Assay Due to Sensitivity Issues

    Microgenics Corporation is recalling specific lots of DRI Salicylate Serum Tox Assay kits because negative patient samples are recovering higher than the product's sensitivity claim.

    Product
    DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2841-2016·2016-09-28

    Siemens IGF-I Reagent Recalled for Incubation Time Defect

    Siemens Healthcare Diagnostics is recalling IGF-I reagents because the required incubation time for pretreatment solution equilibration is 24 minutes, not as previously indicated.

    Product
    IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2770-2016·2016-09-21

    Sysmex Fluorocell PLT Reagent Recalled for Potential Low Platelet Results

    Sysmex America Inc is recalling Fluorocell PLT reagent because it may produce falsely low platelet results on Sysmex XN-Series analyzers.

    Product
    Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2358-2016·2016-08-31

    Alere INRatio2 PT/INR Home Monitoring System Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio2 PT/INR Home Monitoring Systems because they may display inaccurate INR results compared to central laboratory tests.

    Product
    Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2357-2016·2016-08-31

    Alere INRatio2 PT/INR Testing System Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio2 PT/INR Testing Systems because some patients showed significantly higher INR results in central laboratories than on the device.

    Product
    Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2356-2016·2016-08-31

    Alere INRatio PT Monitoring Systems Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio PT Monitoring Systems because they may show lower INR results than central laboratory tests, potentially affecting warfarin therapy.

    Product
    Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2016·2016-08-31

    Alere INRatio PT/INR Test Strips Recalled for Inaccurate Results

    Alere San Diego is voluntarily recalling INRatio test strips because they may report inaccurate INR results, potentially affecting warfarin therapy.

    Product
    Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is app
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2016·2016-08-17

    Siemens Stratus CS STAT Fluorometric Analyzer Software Defect Recall

    Siemens is recalling Stratus CS STAT Fluorometric Analyzers due to a software defect that may cause inaccurate test results or out-of-range values when TestPaks are near expiration.

    Product
    Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531
    Category
    Medical Device
    Distribution
    0 states