Hazard

Diagnostic Inaccuracy recalls

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

What the numbers show

Total: 97
Critical: 0
Severe: 5
Most recent: 2026-08-12

Of the 97 diagnostic inaccuracy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (5%) 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 diagnostic inaccuracy 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.

76–97 of 97

ModerateFDA (Devices)·Z-0610-2019·2018-12-26
Diagnostica Stago Recalls Staclot LA Test Kits Due to Result Variability
Diagnostica Stago is recalling Staclot LA test kits because some results showed shortened times, potentially affecting lupus anticoagulant detection accuracy.
Product
Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0594-2019·2018-12-19
Helena Laboratories Recalls Cascade Abrazo c-ACT-LR Test Cards
Helena Laboratories is recalling Cascade Abrazo c-ACT-LR test cards due to waveform variations that may result in inaccurate clotting time measurements.
Product
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0465-2019·2018-11-21
Siemens Lipase Reagent Cartridge Recall for Lot Variability
Siemens Healthcare is recalling specific lots of Dimension Lipase Flex Reagent Cartridges due to lot-to-lot variability affecting quality control and patient results.
Product
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0115-2019·2018-10-24
Siemens ADVIA Centaur CKMB Master Curve Material Recalled for Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CKMB Master Curve Material due to a potential bias identified when compared to internal standards.
Product
ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1659-2018·2018-05-16
Siemens Creatine Kinase MB Assay Recalled for Drug Interference
Siemens is recalling the Dimension Vista Creatine Kinase MB assay because it may produce inaccurate results when used with certain drugs.
Product
Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1656-2018·2018-05-16
Siemens Dimension Vista ALTI Assay Recalled for Drug Interference
Siemens is recalling Dimension Vista ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.
Product
Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1139-2018·2018-03-28
BD Vacutainer Tubes Recalled for Lead Test Inaccuracy
Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.
Product
BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI: 503829036
Category
Medical Device
Distribution
47 states
ModerateFDA (Devices)·Z-1140-2018·2018-03-28
BD Vacutainer Tubes Recalled for Lead Test Inaccuracy
Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.
Product
BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)
Category
Medical Device
Distribution
47 states
ModerateFDA (Devices)·Z-1142-2018·2018-03-28
BD Vacutainer Tubes Recalled for Lead Test Inaccuracy
Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.
Product
BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50382903680400); 5. 366667 (UDI: 50382903666671); 6. 367880 (UDI: 50382903678803)
Category
Medical Device
Distribution
47 states
ModerateFDA (Devices)·Z-1149-2018·2018-03-28
Medica Wash Kit Recalled for Inconsistent Lipase Test Results
Medica Corporation is recalling Wash Kit REF 10680 because an ineffective wash solution causes inconsistent lipase test results.
Product
Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1141-2018·2018-03-28
BD Vacutainer Tubes Recalled for Lead Test Inaccuracy
Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead in blood samples when used with certain assays.
Product
BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894)
Category
Medical Device
Distribution
47 states
ModerateFDA (Devices)·Z-0979-2017·2017-01-18
Siemens Recalls Intact PTH Assay Kits Due to Negative Bias
Siemens is recalling IMMULITE 2000 Intact PTH assay kits because they may show a negative bias of up to -39% at low concentrations.
Product
SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonw
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0864-2017·2016-12-28
Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Result Bias
Ortho-Clinical Diagnostics is recalling VITROS CRP Slides because the diluent contains endogenous CRP, which can cause falsely high test results if not subtracted.
Product
VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2302-2016·2016-08-10
Ortho-Clinical Diagnostics Recalls VITROS Total T4 Reagent Packs
Ortho-Clinical Diagnostics is recalling VITROS Total T4 Reagent Packs because test results may show a negative bias before the 8-week storage limit.
Product
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (E
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2041-2016·2016-06-29
Siemens ADVIA Centaur Tnl-Ultra Assay Recalled for Biotin Interference
Siemens Healthcare is recalling ADVIA Centaur Tnl-Ultra Assay kits because biotin in patient samples can alter test results by more than 10%.
Product
Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centa
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2025-2016·2016-06-29
Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 25 Biograph mCT Flow 64-4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2021-2016·2016-06-29
Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 28 Biograph mCT Flow 20-4R PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1576-2016·2016-05-04
Drew Scientific Recalls Drew3-PAC Reagent Packs Due to Platelet Background Issues
Jas Diagnostics/Drew Scientific is recalling Drew3-PAC reagent packs because they may cause elevated platelet background during routine analyzer checks.
Product
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-1067-2016·2016-03-16
Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Systems and Strips
Beckman Coulter is recalling iChem VELOCITY urine chemistry systems and strips because loose or missing analyte pads may go undetected by the system.
Product
iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1729-2015·2015-06-17
Ortho-Clinical Diagnostics Recalls VITROS Urine Assay Data Disks
Ortho-Clinical Diagnostics is recalling VITROS Urine Assay Data Disks because a software error may allow samples requiring acidified pretreatment to be metered from the same container as those requiring no pretreatment.
Product
Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1120-2013·2013-04-24
Siemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.
Product
ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0254-2013·2012-11-14
Sysmex XE-2100 Hematology System Recalled for Reticulocyte Count Bias
Sysmex America is recalling 1,099 XE-2100 Automated Hematology Systems because reticulocyte counts may be 21% lower than expected due to a low bias.
Product
Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro dia
Category
Medical Device
Distribution
Distributed nationwide