The Recall Desk

Hazard

Calibration Failure recalls

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

What the numbers show

Total
79
Critical
0
Severe
0
Most recent
2025-10-15

Of the 79 calibration failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 calibration failure 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 79

  • ModerateFDA (Devices)·Z-0844-2019·2019-02-27

    Ortho Vitros Myoglobin Calibrators Recalled for Stability Issues

    Ortho Clinical Diagnostics is recalling Vitros Myoglobin Calibrators due to a stability issue that may cause calibration failures or atypical quality control results.

    Product
    Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2019·2018-11-14

    Ortho-Clinical Diagnostics Recalls VITROS Vitamin B12 Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Reagent Packs due to a potential for increased calibration failures.

    Product
    VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 360
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2062-2018·2018-06-13

    Siemens ADVIA Chemistry Urea Nitrogen Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Urea Nitrogen Reagent due to increased calibration failures that prevent the system from generating results.

    Product
    ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
    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-1184-2018·2018-04-04

    Siemens Dimension Vista LOCI 8 Calibrator Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling the Dimension Vista LOCI 8 Calibrator due to increased failed calibration events and negative bias in Estradiol assays.

    Product
    Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1765-2017·2017-04-19

    Ortho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent Packs Due to Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP Reagent Packs because background signals are increasing, causing calibration failures.

    Product
    VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1255-2017·2017-03-08

    Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias

    Siemens is recalling specific Calibrator A Kits due to a negative bias in FT4 assays and potential calibration failures on certain systems.

    Product
    Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1256-2017·2017-03-08

    Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias

    Siemens is recalling specific Calibrator A kits due to confirmed negative bias and potential calibration failures for the FT4 assay on certain ADVIA Centaur systems.

    Product
    Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2017·2017-03-08

    Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias

    Siemens recalls ADVIA Centaur Calibrator A kits due to negative bias in FT4 assays and potential calibration failures on specific systems.

    Product
    Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1181-2017·2017-02-15

    Ortho VITROS FS Calibrator 1 Recalled Due to Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS FS Calibrator 1, Lot 91461, because it cannot calibrate dLDL reagents when used with specific Assay Data Disk versions.

    Product
    VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 --- Ortho
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2580-2016·2016-08-24

    Ortho-Clinical Diagnostics Recalls VITROS TSH Reagent Packs Due to Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS TSH Reagent Packs because calibration curves frequently fall outside quality parameters, potentially delaying test results.

    Product
    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-1004-2015·2015-01-28

    Ortho-Clinical VITROS Software Recall Due to Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Software Version 3.1 because calibration may not occur when using specific calibrator barcode labels.

    Product
    VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-qua
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2214-2014·2014-08-20

    Ortho-Clinical VITROS Chemistry Calibration Modules Recalled for Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CDM PROM Calibration Data Modules because they prevent the calibration and use of specific ammonia test slides.

    Product
    VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2149-2014·2014-08-13

    Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration

    Siemens is recalling 1,191 BNP immunoassay kits worldwide due to complaints of failed calibration. The kits are used for in vitro diagnostic testing.

    Product
    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2014·2014-08-13

    Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration

    Siemens Healthcare Diagnostics is recalling 961 BNP kits due to complaints of failed calibration. The kits are used for in vitro diagnostic testing of B-type Natriuretic Peptide.

    Product
    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1928-2014·2014-07-02

    Alere Triage BNP Calibrators Recalled Due to Mislabeling

    Alere San Diego is recalling BNP calibrators because a Level 5 bottle contains Level 4 material, causing calibration failures.

    Product
    Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriureti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1648-2014·2014-05-28

    Ortho-Clinical VITROS TT4 Calibrator Recalled for Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS TT4 Calibrators due to potential calibration failures or low quality control results.

    Product
    VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differenti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1490-2014·2014-04-30

    Ortho-Clinical VITROS Chemistry Calibration Data Module Recalled for Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CDM PROM No. 0168 because it lacks calibration parameters for DT CRSC slides, preventing system calibration.

    Product
    VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1083-2014·2014-03-12

    Elekta Integrity Software Recalled for Calibration Input Errors

    Elekta, Inc. is recalling Integrity Version 1.1 software for linear accelerators because incorrect values can be entered during calibration procedures.

    Product
    Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2014·2014-03-12

    Elekta Agility Software Recall for Calibration Input Errors

    Elekta is recalling Agility software version 3.0 because incorrect values can be entered during calibration procedures for medical linear accelerators.

    Product
    Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2014·2014-01-22

    Radiometer pO2 Membrane Units Recalled Due to Incorrect Inner Solution

    Radiometer America is recalling pO2 D999 membrane units because they were produced with the wrong inner solution, causing calibration failures.

    Product
    pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2013·2013-09-18

    Siemens ADVIA Centaur Folate Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling 488 units of ADVIA Centaur Folate reagent due to calibration failures and quality control shifts.

    Product
    ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2172-2013·2013-09-18

    Siemens ADVIA Centaur Folate Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling 44 units of ADVIA Centaur Folate reagent due to calibration failures and significant negative shifts in quality control and patient results.

    Product
    ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2169-2013·2013-09-18

    Siemens ADVIA Centaur Folate Test Kits Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.

    Product
    ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2170-2013·2013-09-18

    Siemens ADVIA Centaur Folate Test Kits Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.

    Product
    ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states