Hazard

Diagnostic Error recalls

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

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.

126–150 of 170

HighFDA (Devices)·Z-1372-2022·2022-07-20
Blood gas test device recalled for inaccurate oxygen measurements
Siemens epoc BGEM Test Cards may produce inaccurate blood oxygen measurements, potentially leading to misdiagnosis and unnecessary respiratory treatment. The recall affects 263 boxes distributed across multiple states.
Product
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1340-2022·2022-07-13
Siemens Dimension LTNI Cardiac Troponin Test Positive Bias Recall
Siemens is recalling the Dimension LTNI cardiac troponin-I test due to positive bias in Lithium Heparin plasma samples, which may cause false-positive results and inappropriate medical intervention.
Product
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1339-2022·2022-07-13
Imaging system software displays mirrored CT images during data loading
Siemens imaging systems with syngo VE20 software may display CT images mirrored horizontally and vertically when loading Toshiba data, potentially causing misinterpretation of patient positioning and inappropriate treatment.
Product
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1341-2022·2022-07-13
Cardiac Troponin Diagnostic Test Recalled for Positive Bias in Plasma Samples
Siemens Dimension CTNI cardiac troponin test is recalled for positive bias (falsely elevated readings) in Lithium Heparin plasma samples, which may lead to misdiagnosis of myocardial infarction.
Product
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1252-2022·2022-06-15
Atellica IM 1300 Analyzers Incompatible with Software Can Produce Erroneous Thyroid Results
Siemens is recalling 1,566 Atellica IM 1300 Analyzers distributed worldwide because certain lots are incompatible with Test Definition version 1.4 and may generate incorrect total T3 thyroid test results.
Product
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1215-2022·2022-06-08
BD Anti-Kappa PE Flow Cytometry Reagent May Show Inaccurate Results
Becton Dickinson is recalling 199 units of BD Anti-Kappa PE flow cytometry reagent because samples may exhibit uncharacteristic flow profiles that could affect test accuracy.
Product
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytom
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1214-2022·2022-06-08
BD Anti-Kappa Flow Cytometry Reagents Recalled for Uncharacteristic Flow Profiles
BD Anti-Kappa APC and PE reagents used in flow cytometry testing may exhibit uncharacteristic flow profiles, potentially affecting test accuracy. Worldwide distribution to 249 units across US states and Taiwan.
Product
BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cyto
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1009-2022·2022-05-18
FDA Recalls Accula SARS-CoV-2 Test for False Positive Risk
Mesa Biotech is recalling approximately 6,162 units of the Accula SARS-CoV-2 Test due to an increased risk of false positive results, which could delay correct diagnosis and treatment.
Product
Accula SARS-CoV-2 Test, REF: COV4100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1075-2022·2022-05-18
X-ray Imaging Systems Have Reversed Spine Positioning Labels
Shanghai United Imaging's digital X-ray systems may display reversed spine positioning labels, potentially causing misdiagnosis and unnecessary repeat radiation exposure for patients.
Product
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1020-2022·2022-05-11
Estradiol diagnostic test kits recalled for falsely elevated results
Siemens Atellica IM Enhanced Estradiol test kits can produce falsely elevated results in plasma specimens, potentially leading to misinterpretation of patient hormone measurements. Approximately 2,044 units worldwide are affected.
Product
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1000-2022·2022-05-04
NeuMoDx COVID-19 test cartridges recalled for false positive risk
NeuMoDx Molecular is recalling diagnostic cartridges used in COVID-19 and flu/RSV tests because of potential for false positive SARS-CoV-2 results, which could lead to incorrect patient management.
Product
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-Co
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0952-2022·2022-04-27
Qiagen therascreen KRAS RGQ PCR Kit Recall: False Positive/Negative Results
Qiagen Sciences LLC is recalling the therascreen KRAS RGQ PCR Kit due to potential false positive or false negative results in KRAS G12C mutation detection. These inaccurate results could invalidate clinical test outcomes.
Product
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0929-2022·2022-04-20
Siemens Atellica CH Hemoglobin A1c Reagent Kits Recalled for Quality Control Issues
Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0883-2022·2022-04-13
Abbott Alinity m HBV Device Misquantitation of Negative Samples
Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.
Product
Alinity m HBV Application Specification File (US and CE)
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0859-2022·2022-04-13
GE SIGNA Excite 3T MRI Systems Recalled Over Potential Image Flip
GE Healthcare is recalling 55 SIGNA Excite 3T MRI systems due to potential for images to be flipped left to right, which could affect diagnostic accuracy. The affected systems were distributed worldwide.
Product
SIGNA Excite 3T. Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0860-2022·2022-04-13
GE Healthcare MRI Systems Recalled Due to Potentially Flipped Images
GE Healthcare has recalled 653 SIGNA MRI systems worldwide due to a potential defect that could flip medical images left to right. This could affect diagnostic accuracy in patient care.
Product
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0836-2022·2022-04-06
Revogene diagnostic device recalled for photomultiplier tube malfunction
Meridian Bioscience is recalling Revogene diagnostic devices due to compromised photomultiplier tubes that may produce false-positive or indeterminate test results.
Product
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0830-2022·2022-04-06
Siemens Magnesium Flex reagent cartridge recalled for imprecision and assay errors
Siemens recalls magnesium reagent cartridges due to imprecision and abnormal assay flags that may cause erroneous diagnostic results and require repeat patient testing.
Product
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0814-2022·2022-03-30
TCL1 Breakapart Probe May Display Unexpected Genetic Signals
Cytocell Ltd. is recalling TCL1 Breakapart FISH probes (Lot 074612) because the diagnostic test may show unexpected signals beyond the intended chromosome target.
Product
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0738-2022·2022-03-16
FDA Recalls Diagnostic Test Strips for False Positive Results
NeuMoDx COVID-19 test strips (Lot 116305 S/L-02) are recalled due to product contamination that increases risk of false positive results. The recall affects 102 boxes distributed in FL, MD, MI, and NY.
Product
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0741-2022·2022-03-16
FISH Diagnostic Probe Kit Color Labeling Error Affects Test Results
Cytocell Ltd. is recalling a Del(5q) Deletion FISH Probe Kit due to incorrect color labeling on probe components. The mislabeling may cause misinterpretation of test results for patients with AML or MDS.
Product
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0659-2022·2022-03-09
COVID-19 Rapid Test Kits Recalled for Risk of False Positive Results
Celltrion DiaTrust COVID-19 Ag Rapid Test kits from lot COVGCCM0008 are being recalled due to reports of false positive results. The affected 243 kits were distributed to six states before the recall.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0589-2022·2022-02-16
QC Blood Culture Identification Panel Recall for Incorrect Antibiotic Susceptibility Test Results
Microbiologics recalls KWIK-STIK blood culture identification quality control panels due to incorrect susceptibility test results. High-level Gentamicin Synergy values were out of specification, risking inaccurate diagnostic guidance.
Product
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2022·2022-01-26
VITROS High Sample Diluent A Reagent Produces Lower Than Expected Results
Ortho-Clinical Diagnostics is recalling VITROS High Sample Diluent A Reagent Pack Lot 2190 because it produces lower than expected TSH test results. The recall affects 1,416 units distributed worldwide.
Product
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0455-2022·2022-01-12
COVID-19 Diagnostic Kit Recall for Inaccurate Test Results
Qiagen Sciences is recalling 376 units of its QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kit due to faulty cartridges that can produce false-negative or false-positive test results.
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Category
Medical Device
Distribution
9 states