The Recall Desk

Hazard

Imprecision recalls

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

What the numbers show

Total
25
Critical
0
Severe
1
Most recent
2024-03-27

Of the 25 imprecision recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (4%) 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 imprecision 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.

1–25 of 25

  • HighFDA (Devices)·Z-1303-2024·2024-03-27

    Access Total T4 thyroxine assay recalled for test imprecision

    Beckman Coulter recalls Access Total T4 thyroxine assay due to imprecision that may cause erroneous or delayed diagnostic results.

    Product
    Access Total T4, REF 33800, IVD, thyroxine reagent assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0830-2022·2022-04-06

    Siemens Magnesium Flex reagent cartridge recalled for imprecision and assay errors

    Siemens recalls magnesium reagent cartridges due to imprecision and abnormal assay flags that may cause erroneous diagnostic results and require repeat patient testing.

    Product
    Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2022·2021-12-01

    Diagnostic thromboplastin reagent recalled due to performance issues

    Instrumentation Laboratory is recalling HemosIL ReadiPlasTin diagnostic reagent kits due to performance issues including imprecision and out-of-range quality controls that could result in inaccurate test results.

    Product
    HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2753-2020·2020-08-12

    Randox Lipase Assay Substrate Recalled for Imprecision in Quality Control

    Randox Laboratories is recalling specific batches of Lipase R2 Substrate due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2751-2020·2020-08-12

    Randox Lipase Assay Reagent Recalled for Imprecision in Quality Control and Patient Samples

    Randox Laboratories is recalling specific batches of Lipase Colorimetric Reagent due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2367-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier II

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier II units because multiple coatings of AMYL Slides show imprecision on control fluids.

    Product
    VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2366-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier I

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier I units because multiple coatings of AMYL Slides show imprecision on control fluids.

    Product
    VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2365-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS AMYL Slides Reagent for Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS AMYL Slides Reagent because multiple coatings show imprecision on control fluids compared to expected standards.

    Product
    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2364-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS AMYL Slides Reagent for Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS AMYL Slides Reagent because multiple coatings show imprecision on control fluids. The product is used for in vitro diagnostic testing.

    Product
    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1363-2020·2020-03-04

    Siemens ADVIA Chemistry Lipase Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Lipase reagents due to customer complaints about failed calibrations and increased imprecision in quality control and patient samples.

    Product
    ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0992-2019·2019-03-20

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Na+ Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Na+ Slides because imprecision in the affected lot may produce biased patient sample and quality control fluid results.

    Product
    VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integra
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0077-2019·2018-10-17

    Instrumentation Laboratory Recalls HemosIL ReadiPlasTin Diagnostic Reagent

    Instrumentation Laboratory is recalling 9,751 kits of HemosIL ReadiPlasTin due to potential imprecision and out-of-range quality controls.

    Product
    Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2018·2018-06-06

    Syva EMIT 2000 Theophylline Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling Lot J1 of the Syva EMIT 2000 Theophylline Assay because it may show increased imprecision when used with a Beckman AU Clinical Chemistry System.

    Product
    Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1471-2017·2017-03-22

    Ortho-Clinical VITROS Lithium Slides Recalled for Imprecision

    Ortho-Clinical Diagnostics is recalling specific lots of VITROS Lithium Slides due to intermittent imprecision in test results.

    Product
    VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720,
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0319-2017·2016-11-02

    Siemens CMV IgM Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling IMMULITE CMV IgM Assay kits due to reported increases in imprecision and high coefficient of variation (CV) values.

    Product
    IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2017·2016-11-02

    Siemens CMV IgM Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 CMV IgM Assay kits due to reported increased imprecision and high coefficient of variation results.

    Product
    IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare Diagno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2017·2016-10-19

    Siemens Rubella IgM Assay Recalled for False Positive Results

    Siemens is recalling specific lots of Rubella IgM assays due to increased false positive and indeterminate results.

    Product
    SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0081-2017·2016-10-19

    Siemens Recalls Rubella IgM Assay Kits Due to False Positive Results

    Siemens is recalling specific lots of Rubella IgM assay kits because they may produce false positive or indeterminate results on certain analyzers.

    Product
    SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2299-2016·2016-08-03

    Siemens Recalls Theophylline Reagent Due to Increased Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Theophylline reagents because they may exhibit increased imprecision when used with certain quality control materials.

    Product
    ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. Copies of IFUs included in submission.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2298-2016·2016-08-03

    Siemens Syva EMIT 2000 Theophylline Reagent Recall for Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Syva EMIT 2000 Theophylline reagents due to potential increased imprecision when used with certain quality control materials.

    Product
    Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2733-2015·2015-09-09

    Beckman Coulter Recalls Access Thyroglobulin Assay Reagent Packs

    Beckman Coulter is recalling Access Thyroglobulin Assay reagent packs because some may exhibit greater than 10% imprecision at low concentrations.

    Product
    Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1178-2013·2013-05-01

    Alere Cholestech LDX hsCRP Test Cassette Recall for Imprecision

    Alere San Diego, Inc. is recalling 2,333 Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassettes due to increased imprecision that may affect quantitative results.

    Product
    The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro di
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2013·2013-04-24

    Abbott Recalls Phenobarbital Reagent Lots Due to Imprecision Issues

    Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots due to imprecision issues that increase with the age of the reagent.

    Product
    Clinical Chemistry Phenobarbital, list number 1E08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0664-2013·2013-01-16

    Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays due to higher imprecision and outliers on Beckman Coulter AU Systems.

    Product
    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0030-2013·2012-10-17

    Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays because they may show higher imprecision when used on Beckman Coulter AU Systems.

    Product
    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
    Category
    Medical Device
    Distribution
    Distributed nationwide