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.

301–325 of 397

  • HighFDA (Devices)·Z-0710-2016·2016-02-10

    Philips Allura Xper OR Table Recall for Image Interpretation Risk

    Philips is recalling Allura Xper FD20 OR Tables because live and still images may be misinterpreted, potentially affecting diagnostic accuracy.

    Product
    Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placemen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0704-2016·2016-02-10

    Philips Allura Xper OR Table Recall for Image Interpretation Error

    Philips is recalling Allura Xper FD10 OR Tables because still images may be misinterpreted as live images during cardiovascular procedures.

    Product
    Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0714-2016·2016-02-10

    Philips Allura Xper OR Table Recalled for Image Interpretation Error

    Philips is recalling Allura Xper OR Tables because still images may be mistaken for live images, potentially affecting diagnostic accuracy.

    Product
    Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0739-2016·2016-02-10

    Horiba Instruments Recalls ABX PENTRA Enzymatic Creatinine Reagent Due to Interference

    Horiba Instruments Inc. is recalling ABX PENTRA Enzymatic Creatinine CP reagent because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0738-2016·2016-02-10

    Horiba ABX PENTRA Cholesterol CP Reagent Recalled for Interference

    Horiba Instruments Inc is recalling 216 units of ABX PENTRA Cholesterol CP reagent because N-acetylcysteine can cause falsely low results.

    Product
    The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a c
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0742-2016·2016-02-10

    Horiba Instruments Recalls ABX PENTRA Triglycerides Assay Due to Interference

    Horiba Instruments Inc is recalling ABX PENTRA Triglycerides CP assays because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with a
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0631-2016·2016-01-27

    Arkray SPOTCHEM II Reagent Test Strips Recalled for Glucose Error

    Arkray Factory USA is recalling specific lots of SPOTCHEM II test strips because they may display inaccurate glucose results for high values.

    Product
    arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0561-2016·2016-01-06

    Beckman Coulter MicroScan Pos Breakpoint Combo Panel Recall

    Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panel Type 20 due to falsely negative Voges-Proskauer results.

    Product
    MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, so
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0558-2016·2016-01-06

    Beckman Coulter MicroScan Pos Combo Panel Recall for False Negatives

    Beckman Coulter is recalling MicroScan Pos Combo panels due to falsely negative Voges-Proskauer results with Staphylococcus aureus.

    Product
    MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0562-2016·2016-01-06

    Beckman Coulter Recalls MicroScan Pos Breakpoint Combo Panels Due to False Negatives

    Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panels because they may produce falsely negative results for Staphylococcus aureus quality control tests.

    Product
    MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, so
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0439-2016·2015-12-30

    Biomerieux Recalls Etest Piperacillin/Tazobactam Tests Due to False Results

    Biomerieux is recalling Etest Piperacillin/Tazobactam tests because they may report false susceptible results for bacteria.

    Product
    Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0401-2016·2015-12-16

    GE Revolution CT Scanners Recalled for Potential Head Scan Artifacts

    GE Medical Systems is recalling 125 Revolution CT scanners worldwide due to potential image artifacts in head scans that may mimic pathology. No injuries have been reported.

    Product
    GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmissi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0341-2016·2015-12-02

    Leica Microsystems Recalls Unstable CD10 Monoclonal Antibody Diagnostic Reagents

    Leica Microsystems is recalling specific lots of Novocastra CD10 antibody reagents because they are not stable up to the labeled expiry date.

    Product
    Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2016·2015-11-25

    Leonhard Lang Recalls ECG Electrodes Due to Signal Transmission Failure

    Leonhard Lang Medizintechnik GmbH is recalling specific lots of ECG electrodes because they may fail to transmit signals or transmit poor signals before expiration.

    Product
    ECG Electrodes: 50007  Stablebase SBW55 50675  Stablebase SBW55-15 58051  Skintact W-60 50547  Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02 5
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0252-2016·2015-11-18

    Biocare Medical Recalls Smooth Muscle Actin Immunohistochemistry Reagents

    Biocare Medical is recalling certain lots of Smooth Muscle Actin reagents because they may stain cell types that should be negative.

    Product
    Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0220-2016·2015-11-11

    Dako EnVision FLEX Visualization Reagent Recalled for Staining Defect

    Dako North America Inc. is recalling specific lots of EnVision FLEX visualization reagent kits due to a buffer defect causing non-specific background staining that interferes with result interpretation.

    Product
    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2016·2015-10-14

    Siemens SOMATOM Force CT Systems Recalled for Software and Firmware Bugs

    Siemens Medical Solutions USA is recalling 21 SOMATOM Force computed tomography systems due to software and firmware bugs.

    Product
    SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2768-2015·2015-09-23

    MedTest DX Control Reconstitution Fluid Recalled for Fill Volume Variation

    MedtestDx, Inc. is recalling 79 kits of MedTest DX Control Reconstitution Fluid due to vial fill volume variations that may cause control results to fall outside suggested ranges.

    Product
    MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2447-2015·2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglob
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2450-2015·2015-09-02

    Siemens Recalls Dimension Vista B2-Microglobulin Reagent Cartridges

    Siemens Healthcare Diagnostics is recalling 1,655 Dimension Vista B2-Microglobulin Flex Reagent Cartridges due to potential reagent contamination that may cause falsely low test results.

    Product
    Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Mea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2351-2015·2015-08-19

    Remel Recalls PathoDx Strep B Grouping Latex Reagent

    Remel Inc is recalling PathoDx Strep B Grouping Latex because a reagent may cause weak reactions, potentially leading to failure to identify target species.

    Product
    PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2339-2015·2015-08-12

    GE Healthcare Recalls MRI Scanners Due to Potential Image Orientation Errors

    GE Healthcare is recalling 82 MRI scanners because a missing spacer may cause images to be flipped left-right with incorrect orientation annotations.

    Product
    GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD
    Category
    Medical Device
    Distribution
    Distributed nationwide