The Recall Desk

Hazard

Measurement Inaccuracy recalls

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

What the numbers show

Total
65
Critical
0
Severe
4
Most recent
2025-07-02

Of the 65 measurement inaccuracy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (6%) 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 measurement inaccuracy 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.

51–65 of 65

  • HighFDA (Devices)·Z-1230-2022·2022-06-15

    Medical imaging software distance and area measurements may display inaccurately

    Centricity Enterprise Web medical imaging software may display inaccurate distance and area measurements when processing magnified or scaled images. The software is distributed to healthcare facilities worldwide.

    Product
    Centricity Enterprise Web
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1097-2022·2022-05-25

    Randox CK MB Calibrator recalled due to calibration inaccuracy affecting test results

    Randox Laboratories has recalled the CK MB Calibrator (lot 4410CK) because it requires recalibration. When used without proper realignment, the calibrator produces test results approximately 6% higher than actual values.

    Product
    CK MB Calibrator, Catalogue Number CK2393
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0440-2022·2022-01-05

    Siemens Atellica CH β2-Microglobulin Assay Lot 211446 Recalled for Measurement Bias

    Siemens Healthcare Diagnostics recalled lot 211446 of the Atellica CH β2-Microglobulin assay due to analytical bias in test results. The assay showed positive bias up to 20.9% at some concentrations and negative bias up to 10.5% at others.

    Product
    Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0274-2022·2021-12-01

    Freelite Human Lambda Free Kit Recalled for Calibration Curve Inaccuracy

    The Binding Site Group recalled 2,254 Freelite Human Lambda Free Kits due to calibration curve issues that may produce higher-than-expected activity readings and affect measurement accuracy.

    Product
    Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2111-2021·2021-07-28

    Ultrasound Imaging Software Recalled for Inaccurate Measurement Estimates

    Caption Health recalled ultrasound imaging software version 1.2.0 due to a bug that includes unintended video frames in its analysis, potentially resulting in incorrect automated ejection fraction and image quality score estimates. The recall affects approximately 15 systems distributed across five U.S. states.

    Product
    Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1415-2021·2021-04-21

    EOS Imaging Recalls EOSedge Systems Due to Measurement Errors

    EOS Imaging is recalling 11 EOSedge systems because they may produce inaccurate 2D measurements and image resizing errors when patients are not positioned antero-posteriorly.

    Product
    The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisitio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0990-2020·2020-02-12

    Cardinal Health Recalls Genius 2 Tympanic Thermometers for Accuracy Drift

    Cardinal Health is recalling Genius 2 Tympanic Thermometers because calibration frequency may not ensure readings stay within the stated accuracy range.

    Product
    Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1237-2019·2019-05-08

    PerkinElmer Recalls DELFIA hCG Kits Due to Measurement Inaccuracy

    PerkinElmer is recalling 31 DELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1238-2019·2019-05-08

    PerkinElmer AutoDELFIA hCG Kit Recalled for Potential Measurement Inaccuracy

    PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2018·2018-02-07

    C.R. Bard Recalls Uros Automated Urine Output and Temperature Monitor

    C.R. Bard is recalling two units of the Uros Automated Urine Output and Temperature Monitor in Florida due to potential measurement inaccuracies.

    Product
    BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2794-2016·2016-09-21

    Siemens Syngo.Plaza VB 10 A PACS Recall for Measurement Suffix Display

    Siemens is recalling 101 Syngo.Plaza VB 10 A image processing systems because a suffix on DICOM images may indicate that displayed measurement values differ from real values.

    Product
    Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2016·2016-08-17

    Merge PACS software recall for inconsistent mammography lesion measurements

    Merge Healthcare is recalling specific versions of Merge PACS software because lesion measurements differ between unmagnified and magnified mammography images.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2031-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error

    Siemens Medical Solutions is recalling 100 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1407-2015·2015-05-06

    GE Healthcare Recalls Six Optima XR220 amx Mobile X-Ray Units

    GE Healthcare is recalling six Optima XR220 amx mobile X-ray units in the US due to potential mAs accuracy inaccuracies.

    Product
    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
    Category
    Medical Device
    Distribution
    5 states