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.

101–125 of 170

HighFDA (Devices)·Z-2578-2023·2023-09-20
Medical Device Recall: ACL TOP Coagulation Analyzers for Sample Misidentification
Instrumentation Laboratory is recalling ACL TOP coagulation analyzers due to potential sample misidentification that could result in incorrect test results and alter patient management decisions.
Product
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2588-2023·2023-09-20
FILMARRAY GI Panel Software Recalled for False Positive Cryptosporidium Results
BioFire Diagnostics is recalling FILMARRAY Gastrointestinal Panel software due to an increased risk of false positive Cryptosporidium test results. Approximately 61,069 devices were distributed in the US and internationally.
Product
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Category
Medical Device
Distribution
54 states
HighFDA (Devices)·Z-1268-2023·2023-09-06
Siemens Atellica CH Analyzer: Reagent Carryover Affecting Magnesium Test Results
Siemens Healthcare Diagnostics has recalled the Atellica CH LDL Cholesterol Direct diagnostic device due to reagent carryover affecting magnesium test accuracy. Approximately 8420 units distributed nationwide and internationally are affected.
Product
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2439-2023·2023-08-30
BioFire Respiratory Panel 2.1 may produce false negative results
BioFire Respiratory Panel 2.1 kits for FILMARRAY systems may return false negative results due to a manufacturing defect. The recall affects 705 kits distributed to healthcare facilities in the U.S. and select international locations.
Product
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-1624-2023·2023-05-31
Incisive CT Power X-Ray System may display flipped or reversed images
The Incisive CT Power X-Ray System (Model 728148) may display computed tomography images with incorrect orientation—flipped or reversed—potentially leading to misdiagnosis, incorrect treatment, or additional radiation exposure from rescanning.
Product
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1505-2023·2023-05-10
Siemens ADVIA Centaur Cortisol Diagnostic Kits Recalled for Negative Measurement Bias
Siemens Healthcare Diagnostics is recalling 18,961 ADVIA Centaur Cortisol diagnostic kits due to negative bias in urine samples causing intermittently low test results that could affect clinical diagnosis.
Product
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and li
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1377-2023·2023-04-19
BioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity
Bio-Rad is recalling BioPlex 2200 Anti-CCP Reagent Pack, Lot 301481, because the test's specificity is lower than claimed, which may increase false positive results. The diagnostic kit was distributed worldwide including the US, Canada, and several European countries.
Product
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1212-2023·2023-03-15
Blood Sample Collection Kits Shipped With Incorrect Identification Labels
LetsGetChecked Blood Sample Collection kits were distributed with incorrect shipping labels that assigned samples to wrong users. This could result in incorrect Hepatitis C Virus test results or rejected samples due to demographic mismatches.
Product
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1105-2023·2023-02-15
Roche cobas Influenza Test Recall Due to False Negative Results
Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.
Product
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1106-2023·2023-02-15
Roche Influenza A/B and RSV Test Kit Recalled for False Negative Results
Roche Molecular Systems recalled 727 diagnostic test kits used to detect influenza and RSV due to reports of false negative influenza A results that could delay proper diagnosis and treatment.
Product
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0907-2023·2023-01-18
VENTANA PD-L1 (SP142) Assay kits recalled for light staining causing false-negative results
Ventana Medical Systems recalled 8,927 VENTANA PD-L1 (SP142) Assay kits worldwide due to light staining that can cause false-negative immunotherapy marker test results affecting cancer treatment decisions.
Product
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0949-2023·2023-01-18
IMMULITE 2000 Thyroglobulin test kits recalled for reduced analytical sensitivity
Siemens is recalling 717 IMMULITE 2000 Thyroglobulin test kits because they may not accurately measure thyroglobulin levels. Inaccurate results could affect monitoring of thyroid cancer patients.
Product
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0473-2023·2022-12-21
BBL Chocolate II Agar laboratory culture media recalled for nutrient deficiency
BBL Chocolate II Agar culture media manufactured by Becton Dickinson contains reduced nutrients and may cause false negative results in laboratory bacterial identification testing.
Product
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0331-2023·2022-12-14
Medical Diagnostic Plate Recalled for False Antibiotic Susceptibility Test Results
Remel Inc is recalling 588 units of the Sensititre Gram Negative IVD AST diagnostic plate due to false susceptible test results for certain bacteria when tested with specific antibiotics. The defect could lead to incorrect treatment decisions.
Product
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0334-2023·2022-12-14
Sensititre STP6F diagnostic plates may report false antibiotic susceptibility results
Remel's Sensititre STP6F diagnostic plates may produce false susceptible results for Gram-negative bacteria when tested with certain antibiotics, potentially leading to inappropriate treatment decisions.
Product
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0329-2023·2022-12-14
Sensititre GN7F Antibiotic Test Plates Recalled for Inaccurate Susceptibility Results
Remel Inc. recalled 8,073 units of Sensititre GN7F antibiotic susceptibility test plates after discovering they may report false results for certain bacteria, potentially leading to incorrect antibiotic treatment decisions.
Product
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0328-2023·2022-12-14
Medical Device Recall: Sensititre GN6F May Report False Antibiotic Susceptibility Results
The FDA recalled Sensititre GN6F Gram Negative antimicrobial susceptibility test plates (2,471 units) because they may report false results indicating bacteria are susceptible to certain antibiotics when they are actually resistant.
Product
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0355-2023·2022-12-14
Siemens IMMULITE Testosterone Assay Recalled for Measurement Bias
Siemens is recalling two lots of its IMMULITE Total Testosterone Assay due to a confirmed 40% positive measurement bias at higher testosterone levels, which may delay diagnosis and require repeat testing.
Product
IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0345-2023·2022-12-07
Accelerate PhenoTest BC Kit Recall Due to False Positive Bacterial Identification
Accelerate Diagnostics is recalling 200 kits of the Accelerate PhenoTest BC diagnostic test due to improperly formulated FISH probes that may produce false positive results for Staphylococcus aureus and Streptococcus bacteria.
Product
Accelerate PhenoTest BC kit REF 10101018
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-0232-2023·2022-11-23
BD Phoenix diagnostic panel misformulated minocycline causes false resistance reporting
BD Phoenix PMIC/ID-107 diagnostic panels contain misformulated minocycline that may produce false antibiotic resistance results, potentially delaying appropriate patient treatment.
Product
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology Syst
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0097-2023·2022-10-26
Medical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies
Roche Molecular Systems recalls the cobas 5800 PCR testing instrument due to false positive and invalid results caused by anomalous baselines. This may lead to erroneous or delayed diagnoses.
Product
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1650-2022·2022-09-07
FGFR cancer diagnostic kit recalled due to increased false positive results
Qiagen Sciences is recalling therascreen FGFR RT-PCR kits due to increased false positive rates. False results could lead patients to receive unnecessary cancer treatment.
Product
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1660-2022·2022-09-07
ARCHITECT STAT Troponin-I Reagent Kit Recalled for Insufficient Blocking Agents
Abbott is recalling one lot of ARCHITECT STAT Troponin-I Reagent Kits due to insufficient heterophilic blocking agents in the conjugate, which may affect test accuracy.
Product
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1652-2022·2022-09-07
RT-PCR Kit Recalled Due to False Positive Test Results
Qiagen's FGFR RGQ RT-PCR Kit may produce false positive results, leading to incorrect lab reports. This could expose cancer patients to inappropriate or suboptimal treatment.
Product
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1462-2022·2022-08-03
Medical imaging software may flip left-right brain image orientation
NordicBrainEX software versions 2.21-2.3.10 may export brain imaging with reversed left-right orientation in certain analysis scenarios, potentially causing diagnostic misinterpretation.
Product
nordicBrainEX, software versions 2.21 through 2.3.10
Category
Medical Device
Distribution
Distributed nationwide