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.

351–375 of 397

HighFDA (Devices)·Z-1564-2014·2014-05-14
Siemens ADVIA Centaur Folate Assay Recalled for Potential Out-of-Range Results
Siemens Healthcare Diagnostics is recalling specific lots of the ADVIA Centaur Folate assay because serum controls may go out of range low and whole blood patient results may shift.
Product
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1530-2014·2014-05-07
Alfa Wassermann ACE AST Reagent Recalled for Low Absorbance Readings
Alfa Wassermann is recalling specific lots of ACE AST Reagent because they produce extremely low absorbance readings, which may affect clinical test results.
Product
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1475-2014·2014-04-30
BioMerieux Recalls ZYM B Reagent Due to Visual Defect and Activity Issue
BioMerieux SA is recalling ZYM B Reagent (REF 70493) because a visual defect and activity issue can cause false negative results in microbiological tests.
Product
ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species ide
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1245-2014·2014-03-26
GE Healthcare Recalls CT Scanners Due to Head Scan Software Artifact
GE Healthcare is recalling Optima CT580 and Discovery CT590RT scanners running software version 13BW16.3 because a software issue may cause artifacts that hide pathology during head scans.
Product
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission d
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1177-2014·2014-03-19
BioMerieux PREVI Isola System Recalled for Potential False Negative Results
BioMerieux is recalling 471 PREVI Isola Systems because they may fail to dispense urine samples, potentially leading to false negative growth results.
Product
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-0831-2014·2014-02-05
Philips Brilliance iCT Systems Recalled for Potential Image Artifacts
Philips Medical Systems is recalling Brilliance iCT and iCT SP systems because an artifact resembling a thrombus may appear on images.
Product
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment su
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0842-2014·2014-02-05
Biomerieux Recalls API Listeria Kits Due to ZYM B Reagent Defect
Biomerieux is recalling API Listeria kits because a defect in the ZYM B reagent may cause false negative results in biochemical tests.
Product
API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM mi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0818-2014·2014-01-29
Siemens Recalls Dimension Vista Cyclosporine Flex Reagent Cartridges
Siemens Healthcare Diagnostics is recalling 1,586 Dimension Vista Cyclosporine Flex reagent cartridges due to complaints about variability in quality control and patient results.
Product
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0344-2014·2013-11-27
Siemens ADVIA Chemistry System Software Recalled for Flagging Errors
Siemens Healthcare Diagnostics is recalling ADVIA 1650 system software due to incorrect ration parameter flagging behavior.
Product
ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0269-2014·2013-11-20
Philips IntelliSpace PACS 4.4 Software Recall for Image Storage Defect
Philips is recalling IntelliSpace PACS 4.4 software due to a timing issue that may prevent the system from storing additional images, potentially affecting clinical diagnoses.
Product
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0180-2014·2013-11-13
Carestream DRX Mobile X-Ray Systems Recalled for Software Defect
Carestream Health is voluntarily patching DRX Mobile X-Ray systems to fix a software issue causing non-diagnostic images.
Product
CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0087-2014·2013-11-06
bioMerieux Recalls chromID Salmonella Agar Due to Colony Color Issues
bioMerieux, Inc. is recalling 90 units of chromID Salmonella Agar because Salmonella strains may grow as white colonies instead of the expected pink to mauve color, potentially leading to missed detections.
Product
chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0090-2014·2013-11-06
Carestream DRX Revolution Mobile X-Ray System Recalled for Image Artifacts
Carestream Health is recalling 23 DRX Revolution Mobile X-Ray Systems because a software update without detector calibration can cause image artifacts.
Product
DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patient
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0013-2014·2013-10-23
Philips CT Scanners Recalled for Image Artifacts During Specific Scans
Philips is recalling 258 CT scanners because artifacts appear on images during threshold-triggered bolus scans using a 0.4-second rotation time.
Product
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cros
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2129-2013·2013-09-18
Siemens Microscan rapID/S panels recalled for false susceptibility results
Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Product
Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2127-2013·2013-09-18
Siemens MicroscanrapID/S panels recalled for antimicrobial misreads
Siemens Healthcare Diagnostics is recalling MicroscanrapID/S panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Product
MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2119-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 1 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 1 panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteri
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2122-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 2 Recall
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 2 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteri
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2121-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Panels Recalled for Misreads
Siemens is recalling Microscan Synergies Plus Negative panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative ba
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2135-2013·2013-09-11
Siemens Recalls ADVIA Chemistry A1c_3 Calibrators Due to Positive Bias
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators because they cause a positive bias of up to 12% in HbA1c test results.
Product
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, N
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1799-2013·2013-07-31
Becton Dickinson Recalls Schaedler K-V Agar Plates Due to Reduced Vancomycin
Becton Dickinson is recalling specific lots of Schaedler K-V Agar plates because they may contain reduced levels of Vancomycin, potentially affecting test accuracy.
Product
BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancom
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1646-2013·2013-07-10
Philips CT Scanners Recalled for Image Artifacts Impairing Diagnostic Quality
Philips is recalling Brilliance CT 64 and Ingenuity Core scanners due to software issues causing image artifacts that may impair diagnostic quality.
Product
Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmis
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1208-2013·2013-05-08
GE Healthcare Recalls 1.5T SIGNA HDe MR Systems for Image Flip Issue
GE Healthcare is recalling 822 GE 1.5T SIGNA HDe MR systems worldwide due to a software issue that may cause left-to-right image flips in specific reformatted views.
Product
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1075-2013·2013-04-17
Tosoh G7 HPLC Analyzer Recalled for Beta-Thalassemia Detection Failure
Tosoh Bioscience Inc is recalling G7 HPLC analyzers because the Beta-thalassemia mode failed to detect the A2 peak in whole blood samples.
Product
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1049-2013·2013-04-10
Siemens Dimension Phosphorus Reagent Cartridge Recalled for Result Interference
Siemens is recalling Dimension Phosphorus reagent cartridges because they can cause falsely low creatinine results when processed near open wells.
Product
Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
Category
Medical Device
Distribution
Distributed nationwide