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.

151–175 of 469

  • HighFDA (Devices)·Z-0068-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling eight BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.

    Product
    BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2763-2019·2019-10-09

    Beckman Coulter Access Cortisol Reagent Recalled for Cross-Contamination

    Beckman Coulter is recalling Access Cortisol Reagent due to cross-contamination that may cause falsely decreased patient results.

    Product
    The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2476-2019·2019-09-11

    Roche cobas e 601 Module Recalled for Inaccurate Results

    Roche Diagnostics is recalling cobas e 601 modules due to a quality issue with high pressure solenoid valves that may cause inaccurate test results.

    Product
    cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2410-2019·2019-09-04

    DRG Salivary Progesterone ELISA Kit Recalled for Low Result Bias

    DRG Instruments GmbH is recalling 8 kits of Salivary Progesterone HS ELISA due to significantly lower results in low measuring ranges.

    Product
    DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2341-2019·2019-08-28

    Siemens N Cuvette Segments Recalled for Falsely Elevated Albumin Results

    Siemens Healthcare Diagnostics is recalling N Cuvette Segments for the BN ProSpec System because they may produce falsely elevated albumin results.

    Product
    N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2346-2019·2019-08-28

    Aniara ZYMUTEST HIA MonoStrip IgG ELISA kit recalled for quality issues

    Aniara Diagnostica LLC is recalling 51 units of the ZYMUTEST HIA MonoStrip IgG ELISA kit due to residual crystallization and out-of-range negative controls.

    Product
    ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2202-2019·2019-08-14

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products GLU Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products GLU Slides due to potentially biased results.

    Product
    VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 In
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2159-2019·2019-08-14

    DRG Salivary Testosterone ELISA Recalled for Inaccurate Low-Range Results

    DRG Instruments GmbH is recalling 38 kits of Salivary Testosterone ELISA because the assay may report testosterone levels that are too low.

    Product
    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2229-2019·2019-08-14

    Siemens Ferritin Reagent Cartridge Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling 815 Dimension Ferritin Flex reagent cartridges due to negative bias. The affected lot is EA9227.

    Product
    Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the d
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-2078-2019·2019-07-31

    Abbott Recalls ARCHITECT BNP Calibrators Due to Stability Drift

    Abbott Laboratories is recalling 5,483 units of ARCHITECT BNP Calibrators worldwide due to a time-dependent stability drift that affects patient and control test results.

    Product
    ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2019·2019-07-10

    Ortho-Clinical VITROS 250 Chemistry System Recalled for CK Result Drift

    Ortho-Clinical Diagnostics is recalling 2,411 refurbished VITROS 250 Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2019·2019-07-10

    Phadia EliA RF IgM Well Recalled for Potential Low Assay Results

    Phadia Ab is recalling EliA RF IgM Well kits due to a potential for reporting low assay results, which may affect rheumatoid arthritis diagnosis.

    Product
    EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2019·2019-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 250AT Chemistry System

    Ortho-Clinical Diagnostics is recalling 57 VITROS 250AT Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1235-2019·2019-05-08

    Siemens Atellica IM aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling 1,489 Atellica IM aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2019·2019-05-08

    PerkinElmer AutoDELFIA hCG Kit Recalled for Inaccurate Low-Range Results

    PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1233-2019·2019-05-08

    Siemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1234-2019·2019-05-08

    Siemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1125-2019·2019-04-17

    Roche cobas c 111 and COBAS INTEGRA 400 plus analyzers recalled for carry-over

    Roche Diagnostics is recalling 137 cobas c 111 and COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.

    Product
    cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1076-2019·2019-04-10

    Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

    Abbott Laboratories is recalling 30 kits of ARCHITECT Creatine Kinase IVD due to a stability issue that may cause error codes or out-of-range quality control results.

    Product
    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1014-2019·2019-03-27

    Siemens Dimension Vista 500 Analyzer Recall for Water Module Contamination

    Siemens is recalling 5,373 Dimension Vista 500 analyzers because specific Millipore water purification modules may cause falsely elevated triglyceride results.

    Product
    Dimension Vista 500, Analyzer, chemistry Model no. 10284473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1015-2019·2019-03-27

    Siemens Dimension Vista 1500 Analyzer Recall Due to Water Module Contamination

    Siemens is recalling 5,373 Dimension Vista 1500 analyzers because specific water purification modules may cause falsely elevated triglyceride results.

    Product
    Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0839-2019·2019-02-27

    Randox Calcium Reagent Recall for Potential Carryover Errors

    Randox Laboratories is recalling Calcium reagents due to a technical bulletin update regarding reagent carryover, which may cause inaccurate test results.

    Product
    Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0798-2019·2019-02-13

    Abbott Recalls Free T3 Reagent Kits Due to Carryover Issues

    Abbott Ireland Diagnostics Division is recalling ARCHITECT Free T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.

    Product
    ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0799-2019·2019-02-13

    Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Carryover

    Abbott Ireland Diagnostics Division is recalling ARCHITECT Total T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.

    Product
    ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS HBeAg Reagent Due to Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS HBeAg Reagent because biotin interference may cause inaccurate test results.

    Product
    VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV
    Category
    Medical Device
    Distribution
    Distributed nationwide