Hazard

Inaccurate Test Results recalls

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

What the numbers show

Total: 63
Critical: 1
Severe: 1
Most recent: 2026-04-29

Of the 63 inaccurate test results recalls we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) 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 test 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.

26–50 of 63

HighFDA (Devices)·Z-1154-2023·2023-03-01
Folate test kits recalled for calibration error causing inaccurate results
Siemens is recalling ADVIA Centaur Folate 500 test kits because a calibration error causes inaccurate, falsely low results when testing serum samples, potentially affecting diagnostic accuracy.
Product
ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siemens Material Number (SMN): 10325366
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0827-2023·2023-01-11
ETEST Clinical Meropenem Susceptibility Test Recalled for Storage Condition Failure
Biomerieux is recalling 3 units of ETEST Clinical Meropenem MP 32 susceptibility test (catalog 412401) nationwide due to storage temperature and time exceedances that cannot guarantee product performance.
Product
ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0822-2023·2023-01-11
FDA Recalls ETEST Ertapenem Antibiotic Susceptibility Test Due to Storage Damage
Biomerieux Inc. is recalling ETEST Clinical Ertapenem antibiotic susceptibility test strips after temperature and time excursions compromised product performance. Affected units cannot guarantee accurate test results.
Product
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0853-2023·2023-01-11
VITEK 2 AST-GN95 Diagnostic Test Kit Recalled for Performance Failure
Biomerieux is recalling the VITEK 2 AST-GN95 test kit because storage temperature and time exceeded acceptable limits, preventing performance guarantees. Eighty-four units were distributed nationwide.
Product
VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0835-2023·2023-01-11
VITEK 2 Antibiotic Susceptibility Test Kits Recalled Due to Storage Condition Failures
Biomerieux Inc is recalling VITEK 2 Reagent AST-GN73 test kits nationwide because they were stored outside proper temperature and time ranges, potentially compromising test accuracy.
Product
VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1675-2022·2022-09-14
VITROS XT 3400 Chemistry System May Produce Inaccurate Test Results
The VITROS XT 3400 Chemistry System may produce inaccurate test results during shutdown due to electrical current shifts. The FDA has classified this Class II recall, affecting 506 units distributed worldwide.
Product
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1639-2022·2022-09-07
AggreGuide A-100 Instrument Software Issue Affecting Test Results
Aggredyne, Inc. is recalling the AggreGuide A-100 Instrument due to a software design defect that causes the device to run assays at 0 RPM, resulting in no blood mixing and inaccurate test results displayed as Low.
Product
AggreGuide A-100 Instrument
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1454-2022·2022-08-03
Abbott Hemoglobin A1c Assay Recalled for Falsely Elevated Test Results
Abbott Laboratories is recalling hemoglobin A1c test reagents used with ARCHITECT and Alinity c analyzers. The assay may produce falsely elevated A1c results, potentially affecting diabetes patient management.
Product
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-0328-2022·2021-12-08
Cholesterol test system recalled due to calibration failure
RANDOX CHOL cholesterol test system is recalled due to a calibration defect that causes quality control results to be flagged as out of range. This could result in inaccurate cholesterol measurements in patient samples.
Product
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0195-2022·2021-11-10
Siemens COVID-19 Diagnostic Assay Recalled for Inadequate Validation Data
Siemens is recalling Atellica IM SARS-CoV-2 Antigen Assay kits because validation data submitted to the FDA was insufficient to confirm the assay's accuracy for its intended use.
Product
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0181-2022·2021-11-03
Siemens Advia Chemistry Urinary Protein Reagent Recall for Inaccurate Test Results
Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.
Product
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2351-2021·2021-09-01
Accu-Chek Aviva Plus Test Strips Recalled for Potential Inaccurate Glucose Readings
Roche Diabetes Care is recalling Accu-Chek Aviva Plus Test Strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to improper treatment decisions.
Product
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1954-2021·2021-07-07
LeadCare Ultra Blood Lead Test Kit Recalled for Control Test Inaccuracy
Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit due to control test failures causing potential underestimation of blood lead levels in patient samples. The recall involves 441 kits with worldwide distribution.
Product
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1295-2021·2021-03-31
Ortho-Clinical Diagnostics Recalls VITROS TIBC Calibrator Kits Due to Performance Shift
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 4 and Fe Slides because TIBC results may be approximately 80 ug/dL lower than expected.
Product
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0523-2021·2020-12-09
Chromsystems Recalls MassChrom Cortisol and Cortisone Saliva Control Level II Kits
Chromsystems is recalling MassChrom Cortisol, Cortisone Saliva Control Level II kits because control lots may not meet stability criteria, potentially causing increased results for patient cortisone samples.
Product
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2551-2019·2019-10-02
Sentinel CH SpA Recalls MULTIGENT Lithium Reagent Kits
Sentinel CH SpA is recalling 15,919 MULTIGENT Lithium reagent kits due to a potential carryover issue that may cause falsely elevated patient results.
Product
MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2279-2019·2019-08-21
BD Vacutainer Fluoride Tubes Recalled Due to Missing Preservative Additive
Becton Dickinson is recalling 247,000 blood alcohol test tubes because they lack the required fluoride additive, which may cause inaccurate test results if samples are stored for more than two days.
Product
BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1933-2019·2019-07-10
Ortho-Clinical Diagnostics Recalls VITROS 250 Chemistry System for CK Drift
Ortho-Clinical Diagnostics is recalling 5,020 VITROS 250 Chemistry Systems due to potential negative drift in Creatine Kinase results.
Product
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) 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) test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1936-2019·2019-07-10
Ortho-Clinical VITROS 350 Chemistry System Recalled for CK Drift
Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.
Product
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) 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) test
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0787-2019·2019-02-13
CoaguChek XS PT Test Strips Recalled for Abnormally High INR Results
Terrific Care LLC is recalling CoaguChek XS PT Test Strips sold via MedEx Supply due to potential for abnormally high INR test results.
Product
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2140-2018·2018-06-20
Immunalysis Recalls EDDP Urine Control Set Due to Specification Failure
Immunalysis is recalling 37 kits of EDDP Urine Control Set 1 because the High control fails to meet specifications, potentially producing inaccurate test results.
Product
lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2097-2018·2018-06-13
Tosoh ST-AIA PACK IGE II Recalled Due to Strensiq Interference
Tosoh Bioscience is recalling ST-AIA PACK IGE II allergy assays because Asfotase Alfa (Strensiq) can cause inaccurate test results.
Product
ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1796-2018·2018-05-16
Siemens Recalls Dimension Lipase Flex Reagent Cartridge Lot FB8109
Siemens Healthcare Diagnostics is recalling one lot of Dimension Lipase Flex Reagent Cartridges due to calibration failure causing positive bias in test results.
Product
Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1685-2018·2018-05-16
Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay kits because the user instructions fail to list the biotin concentration levels that cause test interference. This omission may lead to inaccurate diagnostic results for patients taking biotin supplements.
Product
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1648-2018·2018-05-16
Siemens ADVIA Salicylate Reagent Recalled for Potential Test Interference
Siemens Healthcare Diagnostics is recalling ADVIA Salicylate reagent chemistry assays because various blood, urine, or cerebrospinal fluid assays may interfere with sulfasalazine and sulfapyridine, causing falsely elevated or depressed salicylate results.
Product
ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
Category
Medical Device
Distribution
3 states