The Recall Desk

Hazard

Diagnostic Error recalls

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

What the numbers show

Total
397
Critical
1
Severe
12
Most recent
2026-08-26

Of the 397 diagnostic error recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (3%) 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 diagnostic error 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.

276–300 of 397

  • ModerateFDA (Devices)·Z-0012-2017·2016-10-12

    Philips Ingenuity CT Scanner Recalled for Infant Head Image Quality Issues

    Philips Medical Systems is recalling 235 Ingenuity CT scanners because infant head scans in High Resolution mode may produce degraded image quality, including non-uniformity and CT number shifts.

    Product
    Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0011-2017·2016-10-12

    Philips Ingenuity Core 128 CT Scanner Recalled for Image Quality Defects

    Philips Medical Systems is recalling 524 Ingenuity Core 128 CT scanners because high-resolution head scans may produce degraded image quality, including non-uniformity and CT number shifts.

    Product
    Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2016·2016-08-17

    Philips MX 16-slice CT Systems Recalled for Software Defects

    Philips is recalling 80 MX 16-slice CT systems due to software bugs that may cause image mix-ups or scan interruptions.

    Product
    MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
    Category
    Medical Device
    Distribution
    18 states
  • 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
  • HighFDA (Devices)·Z-2151-2016·2016-07-20

    Novarad NovaPACS Diagnostic Viewer Recall for Image Orientation Flipping

    Novarad Corporation is recalling NovaPACS Diagnostic Viewer software versions 7.4, 7.5, 7.6, and 8.0 because images may flip during streaming, potentially displaying incorrect orientation markers.

    Product
    NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2117-2016·2016-07-06

    Philips Ingenuity Core CT Systems Recalled for Image Artifacts

    Philips is recalling 18 Ingenuity Core CT systems because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.

    Product
    Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2118-2016·2016-07-06

    Philips Ingenuity Core 128 CT Scanner Recalled for Image Artifacts

    Philips is recalling 19 Ingenuity Core 128 CT scanners because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.

    Product
    Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2030-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 47 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 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-1930-2016·2016-06-15

    Beckman Coulter Lipase Reagent Recalled for Potential False Low Results

    Beckman Coulter is recalling Lipase OSR6x30 reagent because Dipyrone may cause erroneous false low results in lipase assays.

    Product
    Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1911-2016·2016-06-15

    Integrated Science Systems Recalls Sure Vue Staph Identification Kits

    Integrated Science Systems is recalling Sure Vue Staph kits due to customer complaints of weak reactions and false negative results.

    Product
    Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2016·2016-06-15

    Beckman Coulter Recalls Triglyceride Assay Due to Dipyrone Interference

    Beckman Coulter is recalling Triglyceride OSR6x118 assays because Dipyrone may cause false low results.

    Product
    Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1932-2016·2016-06-15

    Beckman Coulter Uric Acid Reagent Recalled for False Low Results

    Beckman Coulter is recalling Uric Acid reagent (OSR6x98) because Dipyrone may cause erroneous, false low results in assays.

    Product
    Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1933-2016·2016-06-15

    Beckman Coulter Cholesterol Reagent Recalled for False Low Results

    Beckman Coulter is recalling Cholesterol OSR6x16 reagent because Dipyrone may cause erroneous, false low results in cholesterol assays.

    Product
    Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1662-2016·2016-05-18

    Siemens Uric Acid Assay Recalled Due to Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Uric Acid assays because N-Acetylcysteine and Metamizole can cause falsely low results.

    Product
    Dimension Assays: Uric Acid (URCA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2016·2016-05-18

    Siemens ADVIA Chemistry Glucose Oxidase Assay Recalled for Interference

    Siemens is recalling ADVIA Chemistry Glucose Oxidase Assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1651-2016·2016-05-18

    Siemens recalls Advia Chemistry Assays due to NAC and Metamizole interference

    Siemens Healthcare Diagnostics is recalling Advia Chemistry Assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1500-2016·2016-04-27

    Siemens ADVIA 560 Hematology System Software Recall

    Siemens is recalling ADVIA 560 Hematology Systems because a software defect prevents the system from flagging immature granulocytes and atypical lymphocytes in patient samples.

    Product
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1522-2016·2016-04-27

    Abbott Recalls CELL-DYN Emerald Cleaner Due to Analyzer Quality Control Issues

    Abbott Laboratories is recalling CELL-DYN Emerald Cleaner because it may cause the hematology analyzer to generate out-of-range quality control results for RBC and PLT.

    Product
    CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2016·2016-04-13

    Focus Diagnostics Recalls Simplexa Direct Amplification Discs for Diagnostic Errors

    Focus Diagnostics is recalling Simplexa Direct Amplification Discs because they may cause false test results or error codes.

    Product
    Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1242-2016·2016-03-30

    Siemens IMMULITE 1000 Estradiol Test Recalled for Faslodex Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol Test kits because the drug Faslodex may cause falsely elevated results.

    Product
    IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1243-2016·2016-03-30

    Siemens IMMULITE 2000 Estradiol Test Recalled Due to Faslodex Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol Test kits because the drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.

    Product
    IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1240-2016·2016-03-30

    Siemens Estradiol Test Recalled Due to Potential False Results

    Siemens is recalling ADVIA Centaur Enhance Estradiol tests because the drug fulvestrant may cause falsely elevated results.

    Product
    Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Cent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0808-2016·2016-02-24

    Leica Bond Polymer Refine Red Detection Kits Recalled for Staining Errors

    Leica Microsystems is recalling Bond Polymer Refine Red Detection kits due to a manufacturing error that may cause inadequate staining.

    Product
    Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0730-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.

    Product
    INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and intervent
    Category
    Medical Device
    Distribution
    Distributed nationwide