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.

301–325 of 469

  • HighFDA (Devices)·Z-2273-2016·2016-08-03

    Ortho-Clinical VITROS Calcium Slides Recalled for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Calcium Slides due to potential negatively biased results that may affect diagnosis.

    Product
    VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2241-2016·2016-07-27

    CSL Behring Recalls Dimension Vista Homocysteine Reagent Cartridges

    CSL Behring is recalling 898 units of Dimension Vista Homocysteine Flex Reagent Cartridges because opened lots show reduced stability and do not meet the 7-day claim.

    Product
    Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    36 states
  • LowFDA (Devices)·Z-2119-2016·2016-07-13

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Calibrator Kit 29

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 29 because incorrect calibration mathematics may cause biased test results for total iron-binding capacity.

    Product
    VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Vers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2016·2016-07-06

    Beckman Coulter Recalls Access Free T3 Assay Kits Due to Result Shifts

    Beckman Coulter is recalling Access Free T3 Assay kits because they may show an upward shift in patient results. The recall covers 205,744 kits distributed worldwide.

    Product
    Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2063-2016·2016-07-06

    Medtest Homocysteine Reagent Recalled for Performance Deterioration

    Medtest Holdings is recalling 13 kits of Liquid Stable 2-Part Homocysteine Reagent due to under-recovery of homocysteine in patient samples.

    Product
    Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1923-2016·2016-06-15

    Greiner Bio-One Recalls 4 ml FX Sodium Fluoride Tubes

    Greiner Bio-One is recalling 4 ml FX Sodium Fluoride/Potassium Oxalate tubes because they may contain low or no additives, potentially affecting glucose and lactate test results.

    Product
    4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2016·2016-06-08

    Siemens Dimension Vista 1500 Lab System Software Defect Recall

    Siemens is recalling Dimension Vista 1500 systems due to a software defect that may cause the device to omit a rinse step, potentially leading to discrepant patient results.

    Product
    Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2016·2016-06-08

    Siemens Dimension Vista 500 Lab System Software Defect Recall

    Siemens recalls Dimension Vista 500 systems due to a software defect that may omit probe rinses, potentially causing discrepant patient results.

    Product
    Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures suc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1666-2016·2016-05-18

    Siemens Uric Acid Assays Recalled Due to Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Uric Acid assays because NAC and Metamizole can cause falsely depressed results.

    Product
    Dimension Vista Assays: Uric Acid (URCA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1663-2016·2016-05-18

    Siemens Direct HDL Cholesterol Assay Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Direct HDL Cholesterol assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2016·2016-05-18

    Siemens Recalls Direct HDL Cholesterol Assay Due to Interference

    Siemens Healthcare Diagnostics is recalling the Advia Chemistry Assay: Direct HDL Cholesterol due to potential falsely depressed results caused by NAC or Metamizole interference.

    Product
    Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1651-2016·2016-05-18

    Siemens recalls Advia Chemistry Assays due to NAC and Metamizole interference

    Siemens Healthcare Diagnostics is recalling Advia Chemistry Assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2016·2016-05-18

    Siemens ADVIA Chemistry Enzymatic Creatinine 2 Recalled for Interference

    Siemens is recalling ADVIA Chemistry Enzymatic Creatinine 2 reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test results.

    Product
    ADVIA CHEMISTRY ENZYMATIC CREATININE_2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1660-2016·2016-05-18

    Siemens Dimension Enzymatic Creatinine Assay Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Dimension Assays: ENZYMATIC CREATININE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1657-2016·2016-05-18

    Siemens ADVIA Chemistry Triglycerides Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Triglycerides reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test results.

    Product
    ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1618-2016·2016-05-18

    Siemens Syva Emit Methotrexate Assay Recalled for Stability Failure

    Siemens Healthcare Diagnostics is recalling Syva Emit Methotrexate Assay units because they failed to meet the 20-hour on-board stability claim, potentially causing increased methotrexate values.

    Product
    Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1622-2016·2016-05-18

    Siemens Recalls Dimension Vista BUN Reagent Cartridges for Inaccurate Results

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista BUN Flex reagent cartridges because they may produce inaccurate patient or quality control results.

    Product
    Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1633-2016·2016-05-18

    Siemens Dimension Sirolimus Reagent Cartridge Recalled for Stability Failure

    Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges due to open well instability that may cause inaccurate test results.

    Product
    Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry s
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1659-2016·2016-05-18

    Siemens Direct HDL Cholesterol Assay Recalled for Interference

    Siemens is recalling Direct HDL Cholesterol assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Dimension Assays: Direct HDL Cholesterol (AHDL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2016·2016-05-04

    Hardy Diagnostics Recalls GBS Detect Test Kits Due to Performance Failure

    Hardy Diagnostics is recalling GBS Detect test kits because product deterioration causes poor hemolytic reactions, potentially leading to inaccurate detection of Group B Streptococcus.

    Product
    Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1171-2016·2016-03-23

    Sekisui Diagnostics Recalls Acetaminophen Assay Kits Due to Crystal Formation

    Sekisui Diagnostics is recalling 14,407 Acetaminophen L3K Assay kits because crystal formation in the reagent can cause samples to under-recover.

    Product
    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosi
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1077-2016·2016-03-16

    Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E lots 42 and 43 because they show bias in the testosterone assay.

    Product
    Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Cent
    Category
    Medical Device
    Distribution
    Distributed nationwide