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.

376–400 of 469

  • ModerateFDA (Devices)·Z-0122-2015·2014-10-29

    Siemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 1000 Cortisol Assay reagents due to confirmed positive bias on controls.

    Product
    IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0007-2015·2014-10-08

    Ortho-Clinical Diagnostics Recalls VITROS Phenytoin Slides Due to Potential Bias

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results, potentially affecting patient care.

    Product
    VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2651-2014·2014-09-24

    Beckman Coulter Recalls Coulter DxH Diluent Due to Elevated Platelet Background Counts

    Beckman Coulter is recalling Coulter DxH Diluent because it may cause elevated platelet background counts, resulting in failed Daily Checks on specific Coulter Cellular Analysis Systems.

    Product
    Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2014·2014-08-27

    Siemens Dimension Chemistry Wash Recalled for Inaccurate Test Results

    Siemens Healthcare Diagnostics is recalling Dimension Chemistry Wash lot RD41041 because it caused accuracy shifts in specific patient and QC test results.

    Product
    Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2014·2014-08-20

    Ortho-Clinical Diagnostics Recalls VITROS CA 19-9 Reagent Packs and Calibrators

    Ortho-Clinical Diagnostics is recalling VITROS CA 19-9 Reagent Packs and Calibrators, Lot 1320, because they may produce positively biased results on specific VITROS systems.

    Product
    VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2058-2014·2014-07-23

    Siemens Coat-A-Count Direct Androstenedione Assay Recalled for Inaccurate Results

    Siemens Healthcare Diagnostics is recalling Coat-A-Count Direct Androstenedione assays because they show higher frequency of results greater than 10 ng/mL compared to other platforms.

    Product
    Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1926-2014·2014-07-02

    Siemens Dimension LOCI Troponin I Calibrator Recalled for Result Shifts

    Siemens is recalling Dimension LOCI Troponin I Calibrators because they may cause a 24% upward shift in test results.

    Product
    Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1791-2014·2014-06-25

    Roche cobas 6000 Analyzer Filters Recalled for Potential Aspiration Issues

    Roche Diagnostics is recalling cobas 6000 analyzer filters that may cause discrepant results and system alarms.

    Product
    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2014·2014-06-25

    Roche MODULAR ANALYTICS EVO Serum Work Area Filter Recall

    Roche Diagnostics is recalling 462 Serum Work Area filters for the MODULAR ANALYTICS EVO analyzer due to potential loose components that may cause discrepant results and system alarms.

    Product
    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2014·2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Performance Shift

    Abbott Laboratories is recalling 7,780 kits of ARCHITECT Intact PTH Calibrators because a performance shift may cause falsely elevated patient results.

    Product
    ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1656-2014·2014-06-04

    Siemens ADVIA Centaur VitD 100 Test Recalled Due to Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems VitD 100 test kits because fluorescein samples may interfere with assay results.

    Product
    ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1546-2014·2014-05-14

    Alere INRatio2 Test Strips Recalled for Inaccurate INR Results

    Alere San Diego, Inc. is recalling INRatio2 PT/INR Professional Test Strips because they may report inaccurately low INR results, potentially affecting warfarin therapy monitoring.

    Product
    Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1537-2014·2014-05-14

    Bio-Rad Variant II beta-thalassemia Short Program kits recalled for buffer issues

    Bio-Rad is recalling Variant II beta-thalassemia Short Program kits because buffer issues may cause calibration and quality control failures.

    Product
    Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separatio
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1518-2014·2014-05-07

    Siemens Recalls IMMULITE 2000 Total IgE Assays Due to Positive Bias

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 2000 Total IgE assays because they show a 23% positive bias against the WHO standard.

    Product
    IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1531-2014·2014-05-07

    Siemens IMMULITE Androstenedione Assay Recalled for Over-Recovery

    Siemens recalls IMMULITE Androstenedione assays because they over-recover samples above 5.5 ng/mL, contradicting the stated 10 ng/mL linearity limit.

    Product
    IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1520-2014·2014-05-07

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Diluent Packs Due to Inaccurate Results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Diluent Pack 3 because internal testing found it may cause C-Reactive Protein test results to be approximately 51% lower than expected when used for dilution.

    Product
    VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2014·2014-05-07

    Alfa Wassermann ACE ALT Reagent Recalled for Low Absorbance Readings

    Alfa Wassermann is recalling 731 kits of ACE ALT Reagent due to extremely low absorbance readings that may affect test accuracy.

    Product
    Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1519-2014·2014-05-07

    Ortho-Clinical Diagnostics Recalls VITROS Specialty Diluent Due to Inaccurate CRP Results

    Ortho-Clinical Diagnostics is recalling VITROS Specialty Diluent because it may cause C-Reactive Protein test results to be approximately 51% lower than expected.

    Product
    VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1470-2014·2014-04-23

    Ortho-Clinical Diagnostics Recalls VITROS Carbamazepine Slides Due to Potential Bias

    Ortho-Clinical Diagnostics is recalling VITROS CRBM Slides, Lot 3920-0080-8403, because they may produce biased carbamazepine results.

    Product
    VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS an
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1436-2014·2014-04-16

    Clinical Diagnostic Solutions Recalls Hematology Control Material Due to Elevated MCV

    Clinical Diagnostic Solutions is recalling Boule Con-Diff Tri-Level Hematology Control material because of elevated MCV results in specific lots.

    Product
    Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1193-2014·2014-03-19

    Ortho-Clinical Diagnostics Recalls VITROS Vitamin D Calibrators for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 25-OH Vitamin D Total Calibrators because they may generate negatively biased results. Users must immediately discontinue use of all current lots.

    Product
    VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2014·2014-02-12

    Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes

    Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Centaur Phenytoin Calibrator N because a change in recovery was observed compared to previous lots.

    Product
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2014·2014-02-12

    ITC-Nexus Dx Recalls Hemochron Jr. Citrate APTT Cuvettes for Inaccurate Results

    ITC-Nexus Dx is recalling Hemochron Jr. Citrate APTT Cuvettes because they may produce higher than expected results in normal individuals.

    Product
    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0868-2014·2014-02-05

    Siemens Free T3 Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.

    Product
    T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK Siemens Healthcare Diagnost
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0867-2014·2014-02-05

    Siemens Free T3 Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.

    Product
    T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits --- Origin: UK Siemens Healthcare Diagnostics Products Lt
    Category
    Medical Device
    Distribution
    Distributed nationwide