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.

51–75 of 469

  • HighFDA (Devices)·Z-1022-2022·2022-05-11

    Estradiol Diagnostic Test Recall: Risk of Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol diagnostic test kits (all lots) due to falsely elevated results in plasma specimens. These inaccurate results could lead clinicians to misinterpret patient data.

    Product
    Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2022·2022-05-11

    Estradiol Diagnostic Device Recalled for Falsely Elevated Test Results

    An estradiol diagnostic device has been recalled because it produces falsely elevated test results in plasma specimens. These inaccurate results could cause clinicians to misinterpret patient test results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2022·2022-05-11

    Siemens ADVIA Centaur Estradiol Test Recalled for Falsely Elevated Results

    Siemens Healthcare is recalling all lots of the ADVIA Centaur Enhanced Estradiol diagnostic test because plasma specimens can produce falsely elevated results, potentially leading clinicians to misinterpret patient results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2022·2022-05-11

    In Vitro Diagnostic Estradiol Test Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol (eE2) 500T diagnostic kits that produce falsely elevated test results in plasma specimens, which could lead clinicians to misinterpret patient results.

    Product
    Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2022·2022-04-20

    Siemens Atellica CH Calcium_2 Reagent Carryover Recall

    Siemens is recalling Atellica CH Calcium_2 diagnostic reagent due to potential reagent carryover that could impact quality control, patient samples, and calibrator results. The recall affects approximately 2,395 units distributed globally and in the US.

    Product
    Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2022·2022-01-26

    VITROS High Sample Diluent A Reagent Produces Lower Than Expected Results

    Ortho-Clinical Diagnostics is recalling VITROS High Sample Diluent A Reagent Pack Lot 2190 because it produces lower than expected TSH test results. The recall affects 1,416 units distributed worldwide.

    Product
    VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0272-2022·2021-12-01

    Clinical Chemistry Analyzer Software Defects May Produce Inaccurate Results

    Abbott ARCHITECT clinical chemistry analyzers with software 9.41 and earlier contain defects affecting calibration, sample handling, and quality control that may produce inaccurate diagnostic results.

    Product
    ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0271-2022·2021-12-01

    Abbott ARCHITECT Analyzer Software Issues May Cause Inaccurate Test Results

    Abbott is recalling approximately 20,994 ARCHITECT i1000SR, i2000SR, and i2000 automated analyzers due to 12 software-related issues in version 9.41 and earlier that may produce inaccurate diagnostic test results.

    Product
    ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0214-2022·2021-11-17

    T4 EIA Diagnostic Kit Recall Due to Shelf-Life Quality Standards Failure

    BioCheck, Inc. is recalling 314 T4 EIA Kit units due to failed shelf-life standards that resulted in failed quality control tests. The kits were distributed to five U.S. states and three overseas countries.

    Product
    T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2424-2021·2021-09-15

    Atellica IM Diagnostic Test Kit Recalled for Calibration Interval Deficiency

    Siemens Healthcare recalls the Atellica IM BR 27.29 diagnostic test kit because it does not maintain the claimed 10-day calibration interval; the required interval has been shortened to 3 days to ensure accurate results.

    Product
    Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2199-2021·2021-08-11

    Diagnostic Reagent Stability Issues Lead to Out-of-Range Quality Control Values

    Stanbio Laboratory is recalling Beta-Hydroxybutyrate LiquiColor diagnostic reagent due to reagent deterioration that causes lower than expected or out-of-range quality control values, affecting test accuracy.

    Product
    Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1939-2021·2021-06-30

    OneTouch Delica Lancets Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.

    Product
    ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2021·2021-06-30

    FREESTYLE LIBRE 14 DAY glucose monitoring system recalled for temperature exposure

    Cardinal Health is recalling 8,959 glucose monitoring kits due to temperature exposure during shipping that may result in inaccurate readings. Affected devices were distributed nationwide.

    Product
    FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2021·2021-06-30

    SARS-CoV-2 IgG II Calibrator Results Potentially Multiplied by 1000

    Beckman Coulter's Access SARS-CoV-2 IgG II Calibrator may return test results inflated by up to 1000-fold due to software errors, potentially misrepresenting patient immune status.

    Product
    Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1905-2021·2021-06-30

    SARS-CoV-2 IgG II reagent may produce falsely elevated results in certain software versions

    This diagnostic reagent may multiply test results by 1000x in certain software versions, leading to falsely elevated readings. The Class II recall affects 13,337 units distributed in the US and internationally.

    Product
    Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1940-2021·2021-06-30

    OneTouchDelica Lancets Recalled Due to Temperature Exposure During Shipping

    Cardinal Health Inc. is recalling OneTouchDelica Lancets 33G because devices were exposed to freezing temperatures (31.9°F) during shipping, which may cause inaccurate test results.

    Product
    ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1936-2021·2021-06-30

    OneTouch Ultra Blue test strips recalled for temperature exposure damage

    Cardinal Health is recalling 5,356 boxes of OneTouch Ultra Blue test strips after units were exposed to freezing temperatures during shipping, which may cause inaccurate glucose readings.

    Product
    ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2021·2021-06-30

    Prefilled Pen Needles Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling 1,599 boxes of prefilled pen needles that were exposed to low temperatures during shipping, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2021·2021-06-30

    Freestyle Lancets 28G Recalled Due to Temperature Damage During Shipping

    Cardinal Health is recalling Freestyle Lancets due to temperature exposure during shipping that may cause inaccurate results. Affected devices were distributed in Florida, Georgia, and South Carolina.

    Product
    FREESTYLE LANCETS 28G 100CT Item Number:2975670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1937-2021·2021-06-30

    OneTouch Ultrasoft Lancets recalled due to temperature exposure during shipping

    Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.

    Product
    ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1941-2021·2021-06-30

    OptiChamber Diamond Spacer Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling 375 OptiChamber Diamond Spacer devices due to temperature exposure during shipping that may cause inaccurate medication delivery results. Affected devices were distributed to Florida, Georgia, and South Carolina.

    Product
    OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2021·2021-06-30

    OneTouch Ultra Test Strips Recalled for Potential Inaccurate Glucose Readings

    Cardinal Health Inc. is recalling OneTouch Ultra Test Strips (item 3510443) because temperature excursions during shipping may have compromised glucose measurement accuracy.

    Product
    ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1942-2021·2021-06-30

    Blood Glucose Test Strips Recalled for Temperature Exposure During Shipping

    Cardinal Health is recalling ACCU-CHEK SMARTVIEW 100 test strips distributed in Florida, Georgia, and South Carolina due to temperature excursions during shipping that may cause inaccurate glucose readings.

    Product
    ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2021·2021-06-02

    Roche Recalls Iron Gen 2 Reagent Cassettes Due to Discrepant Results

    Roche Diagnostics is recalling 20,468 Iron Gen 2 reagent cassettes because they may produce discrepant elevated results on specific analyzers.

    Product
    IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1187-2021·2021-03-17

    Tosoh Thyroglobulin Antibody Calibrator Recalled for Calibration Failures

    Tosoh Bioscience Inc is recalling specific lots of Thyroglobulin Antibody Calibrators because some combinations with AIA PACKS resulted in unacceptable calibration values.

    Product
    Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the dia
    Category
    Medical Device
    Distribution
    Distributed nationwide