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.

26–50 of 469

  • HighFDA (Devices)·Z-0352-2024·2023-11-29

    Roche Tina-quant D-Dimer Test System Recalled for Inaccurate Results

    Roche is recalling Tina-quant D-Dimer Test System kits because they produce elevated results when used with lithium-heparin plasma samples, potentially affecting diagnostic accuracy.

    Product
    Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2024·2023-11-01

    Pregnancy Test Kits Recalled Due to Unverified Manufacturing and Unauthorized Distribution

    Universal Meditech Inc. is recalling PrestiBio Rapid Detection Pregnancy Test Midstream kits (manufactured after March 2021) because the company distributed them without FDA authorization and cannot verify manufacturing compliance.

    Product
    PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0056-2024·2023-11-01

    Ketone Test Strips Recalled for Lack of FDA Marketing Authorization

    Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide post-market support.

    Product
    PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2473-2023·2023-09-06

    Diagnostic reagent kit recall: potential test result inaccuracy

    Siemens is recalling Atellica CH diagnostic reagent kits due to potential reagent carryover that could produce inaccurate test results. This may affect quality control and patient test reliability.

    Product
    Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2023·2023-09-06

    Atellica CH Triglycerides Diagnostic Kit Recalled for Reagent Carryover

    Siemens Healthcare Diagnostics is recalling 11,824 units of Atellica CH Triglycerides test kits due to reagent carryover from other test parameters that can affect magnesium measurement accuracy. The FDA classified this as a Class II recall.

    Product
    Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2023·2023-09-06

    FDA Recalls Siemens epoc BGEM Crea Test Cards for Inaccurate Glucose Results

    Siemens Healthcare is recalling epoc BGEM Crea Test Cards that may produce inaccurate glucose readings in lower-range samples. 473 units were distributed to US facilities and international locations. No injuries reported.

    Product
    epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1269-2023·2023-09-06

    Siemens Atellica CH Total Protein II Recalled for Reagent Carryover

    Siemens Healthcare Diagnostics is recalling Atellica CH Total Protein II due to reagent carryover affecting magnesium test accuracy. The recall covers all lots (13,071 units) distributed nationwide and internationally.

    Product
    Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2451-2023·2023-08-30

    ADVIA Chemistry Urinary Protein Reagent Carryover Causing Incorrect Creatinine Results

    A reagent carryover issue in Siemens ADVIA Chemistry urinary protein test kits can cause falsely low creatinine test results. The problem occurs when the creatinine test is run after the protein test on the same system.

    Product
    ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2023·2023-07-19

    Ortho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 20 due to measurement bias affecting laboratory results for immunoglobulin and complement protein testing. Falsely elevated or reduced values could be reported.

    Product
    VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2023·2023-05-17

    STA Compact Max analyzer firmware bug causes inaccurate test results

    A firmware bug in Diagnostica Stago's STA Compact Max analyzer causes intermittent shortened coagulation times and frequent technical errors that produce inaccurate lab test results. Five units were distributed to clinical laboratories nationwide.

    Product
    STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1504-2023·2023-05-10

    Siemens Atellica cortisol kits recalled for negative bias in urine testing

    Siemens Healthcare Diagnostics recalls 34,746 Atellica IM Cortisol diagnostic kits due to negative bias in urine test results, which may produce inaccurately low cortisol measurements.

    Product
    Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1016-2023·2023-02-01

    Intraoperative PTH Test Kits Recalled Due to High Result Variability

    Future Diagnostics recalled STAT-IntraOperative-Intact-PTH immunoassay kits due to high coefficient of variability in test results. 342 kits were distributed worldwide.

    Product
    Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0787-2023·2023-01-11

    VITEK 2 Reagent GN Test Kit Recalled Due to Storage Condition Exceedance

    Biomerieux Inc. is recalling 348 units of VITEK 2 Reagent GN Test Kit due to temperature and time storage parameter exceedance that may affect diagnostic performance. No illnesses reported.

    Product
    VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2023·2023-01-11

    ETEST Antibiotic Susceptibility Test Kit Recalled for Storage Degradation

    Biomerieux Inc recalled ETEST antibiotic susceptibility test kits from batch 1009384490 due to storage conditions exceeding safe temperature and time parameters, potentially affecting test accuracy.

    Product
    ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2023·2023-01-11

    Biomerieux VIDAS RUB IGG Tests Recalled Due to Storage Conditions

    Biomerieux is recalling VIDAS RUB IGG diagnostic tests nationwide after storage temperature and duration exceeded specifications, affecting product performance guarantees.

    Product
    VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2023·2023-01-11

    Medical Diagnostic Device Recalled Due to Temperature and Time Excursions

    Biomerieux Inc. is recalling PPM LOMBARD diagnostic products due to storage temperature and time conditions being exceeded during distribution, which compromises the product's guaranteed performance.

    Product
    PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2023·2023-01-11

    Measles Antibody Test Kits Recalled Due to Temperature Excursion

    Biomerieux Inc recalled VIDAS Measles IgG diagnostic test kits due to temperature and time excursions during storage or transport. Affected batch 1009421810 distributed nationwide; product performance cannot be guaranteed.

    Product
    VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0349-2023·2022-12-07

    Hemoglobin A1c Control Material Produces Incorrect Test Results

    A. MENARINI diagnostics hemoglobin A1c control materials (Lot 12161) are producing incorrect results that cause analyzer errors and prevent diagnostic testing. Facilities using this lot should discontinue use and contact the manufacturer.

    Product
    A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0080-2023·2022-10-19

    Clip COVID Rapid Antigen Test Kit Recalled for Unapproved Shelf-Life Extension

    LUMINOSTICS recalled Clip COVID test kits because the manufacturer extended shelf life and expiration dates without FDA approval. The extended expiration dates lack FDA validation.

    Product
    Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2022·2022-09-14

    Laboratory diagnostic system may report inaccurate results during shutdown

    The VITROS XT 7600 laboratory analyzer may report inaccurate test results when the system performs a shutdown. The issue affects approximately 1,148 units distributed worldwide.

    Product
    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1508-2022·2022-08-17

    Cholestech LDX cholesterol test cassettes require bilirubin interference label update

    Alere is updating the package insert for Cholestech LDX cholesterol test cassettes to disclose that samples with elevated bilirubin can produce inaccurate triglyceride and HDL results. Approximately 436,990 units are affected.

    Product
    The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Devices)·Z-1422-2022·2022-07-27

    Laboratory Reagent Recalled Due to Inaccurate Calibration Curves

    Randox Laboratories is recalling Soluble Transferrin Receptor reagent (TF10159) due to calibration curve defects causing inaccurate test results on Siemens Atellica CH analyzers.

    Product
    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1423-2022·2022-07-27

    Soluble Transferrin Receptor Calibrator Recall Due to Lab Errors

    Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator kits used in lab analyzers. The calibrators can produce incorrect test results, with some values potentially underestimated by up to 30 percent.

    Product
    Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2022·2022-05-25

    FDA Recalls VITROS Immunodiagnostic LH Reagent Pack for measurement imprecision

    Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control results.

    Product
    VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2022·2022-05-25

    VITROS Prolactin Reagent Recalled for Low-End Measurement Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS Prolactin Reagent packs due to low-end measurement imprecision that may cause falsely high or delayed test results. Approximately 1,767 affected units are distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
    Category
    Medical Device
    Distribution
    Distributed nationwide