The Recall Desk

Hazard

Inaccurate Diagnostic Results recalls

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

What the numbers show

Total
31
Critical
0
Severe
0
Most recent
2026-05-06

Of the 31 inaccurate diagnostic 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 inaccurate diagnostic 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.

1–25 of 31

  • HighFDA (Devices)·Z-2000-2026·2026-05-06

    i-STAT Blood Gas Analyzer Cartridges Recalled for Inaccurate Results

    Abbott is recalling certain i-STAT EG6+, EG7+, and G3+ blood gas cartridges that may report falsely high CO2 and falsely low pH results due to a manufacturing issue, potentially leading to unnecessary or harmful clinical interventions.

    Product
    i-STAT EG6+ cartridge; List Number: 03P77-25;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2970-2020·2020-09-23

    Siemens epoc BGEM Test Card Recalled for Inconsistent Glucose Results

    Siemens Healthcare Diagnostics Inc is recalling specific lots of epoc BGEM Test Cards due to sporadically inconsistent low glucose results that could delay diagnosis or cause unnecessary treatment.

    Product
    Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2968-2020·2020-09-23

    Tosoh Bioscience Recalls AIA-PACK BHCG Calibration Sets Due to Stability Issues

    Tosoh Bioscience is recalling 39 boxes of AIA-PACK BHCG Calibration Sets due to decreased stability that may cause inaccurate HCG concentration measurements.

    Product
    Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2545-2020·2020-07-15

    Centurion Difficult IV Kit Recalled for False Carboxyhemoglobin Results

    Centurion Medical Products is recalling 140 Difficult IV Kits containing BD Vacutainer tubes that may cause false carboxyhemoglobin results.

    Product
    Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit Code: IV8860
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2020·2020-02-26

    Siemens Recalls ADVIA Chemistry CardioPhase hsCRP Calibrator Due to Accuracy Drift

    Siemens Healthcare Diagnostics is recalling 844 units of ADVIA Chemistry CardioPhase hsCRP Calibrator because accuracy has drifted from reference materials, causing high bias in quality control and patient sample recovery.

    Product
    ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling specific blood collection tubes because they can cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2307-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer PST Gel and Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling specific blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2308-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they can cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2301-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling specific blood collection tubes because they may cause falsely elevated carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2993-2018·2018-09-19

    Diagnostica Stago Recalls STA N¿oplastine¿ CI Plus Reagents Due to Quality Control Failures

    Diagnostica Stago is recalling 24,043 kits of STA N¿oplastine¿ CI Plus reagents because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.

    Product
    Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3044-2018·2018-09-19

    Ortho-Clinical VITROS Chloride Slides Recalled for Interference Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2836-2018·2018-08-22

    DRG Instruments Recalls Salivary Estradiol ELISA Kits Due to Measurement Errors

    DRG Instruments GmbH is recalling 169 Salivary Estradiol ELISA kits because poor differentiation between standards may cause lower recovery of estradiol levels.

    Product
    Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1812-2018·2018-05-23

    Tosoh HbA1c Pretreatment Solution Recalled for Potential Inaccurate Test Results

    Tosoh Bioscience Inc is recalling HbA1c Pretreatment Solution because it may cause erroneously elevated or decreased patient test results.

    Product
    Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2018·2018-03-21

    Diagnostica Stago Recalls Neoplastine Cl Plus Prothrombin Time Reagent Kits

    Diagnostica Stago is recalling 1,636 Neoplastine Cl Plus kits due to a defect causing inaccurate prothrombin time test results.

    Product
    Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1120-2017·2017-02-08

    Siemens IMMULITE PSA Kit Recall Due to Negative Bias Results

    Siemens is recalling two lots of IMMULITE PSA kits because they produce negative bias results, potentially affecting prostate cancer screening accuracy.

    Product
    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in huma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2017·2016-11-23

    Roche Recalls Hemoglobin A1c Test Cassettes Due to High Results

    Roche Diagnostics is recalling specific Hemoglobin A1c test cassettes because they may produce erroneously high results.

    Product
    COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1670-2016·2016-05-25

    Siemens ADVIA Chemistry Triglyceride Reagent Recalled for Linearity Defects

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Triglyceride reagent lots 348297 and 359932 because they fail linearity claims near end of shelf life.

    Product
    ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0825-2016·2016-03-02

    Siemens BCS XP Analyzer Recalled for False Clotting Results

    Siemens Healthcare Diagnostics is recalling BCS XP Automated Blood Coagulation Analyzer Systems because they may produce falsely short clotting times and low INR values for specific patient samples.

    Product
    BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0740-2016·2016-02-10

    Horiba ABX PENTRA Glucose Reagent Recalled for NAC Interference

    Horiba Instruments Inc is recalling ABX PENTRA Glucose reagents because N-acetylcysteine in patient blood can cause falsely low glucose results.

    Product
    ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0340-2016·2015-12-02

    Siemens ADVIA Chemistry Hemoglobin A1c Reagent Kits Recalled for Bias

    Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Chemistry Hemoglobin A1c reagent kits due to a positive bias that may result in inaccurate test results.

    Product
    ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0160-2016·2015-11-04

    LifeHealth Recalls BG Cartridges for IRMA TRUPOINT Blood Gas Analyzer

    LifeHealth is recalling BG cartridges for the IRMA TRUPOINT Blood Gas Analyzer because the pH sensor may provide falsely elevated results as the product ages.

    Product
    BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2015·2014-12-31

    Instrumentation Laboratory Recalls HemosIL PT-Fibrinogen HS PLUS Reagent

    Instrumentation Laboratory is recalling HemosIL PT-Fibrinogen HS PLUS reagent kits because some vials exhibit discoloration that causes prolonged prothrombin clotting times.

    Product
    HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coag
    Category
    Medical Device
    Distribution
    Distributed nationwide