Hazard

Diagnostic Accuracy recalls

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

What the numbers show

Total: 18
Critical: 0
Severe: 0
Most recent: 2026-07-29

Of the 18 diagnostic accuracy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 accuracy 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.

1–18 of 18

HighFDA (Devices)·Z-2777-2026·2026-07-29
Emano Flow Uroflowmetry App Recalled Over Biased Flow Estimates
Emano Metrics is recalling 685 units of the Emano Flow smartphone-based acoustic uroflowmetry app (v2.0.0) because recordings captured at 48,000 Hz were processed by models trained on 44,100 Hz audio, producing systematically biased urinary flow rate and voided volume estimates.
Product
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volume from the acoustic signal of urination. No physical components. Distributed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1806-2026·2026-04-22
Yeastone Broth recalled because it may report incorrect susceptibility results
Yeastone Broth is being recalled because the product may report incorrect antifungal susceptibility results during quality control, which could delay treatment or force a change of agent.
Product
Yeastone Broth, 11ML, 10/BOX YY3462
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1794-2026·2026-04-15
MicroScan multidrug resistance test panels recalled over incorrect processing
MicroScan Neg Multidrug Resistant MIC 1 panels are being recalled because of a manufacturing issue involving incorrect processing of the in vitro multidrug resistant test. Three boxes are affected.
Product
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agen
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1772-2026·2026-04-15
MicroScan susceptibility panels recalled over missing drug and doubled antibiotic
Beckman Coulter is recalling MicroScan Neg MIC 3J panels because a manufacturing issue left one well missing a drug while containing double the amount of antibiotics.
Product
MicroScan Neg MIC 3J REF C54814
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1795-2026·2026-04-15
Preeclampsia growth factor assay recalled over out-of-range quality control values
B.R.A.H.M.S PlGF Plus KRYPTOR in vitro diagnostic tests are being recalled after customers observed out-of-range values at the lowest quality control level, which can contribute to falsely elevated results.
Product
B¿R¿A¿H¿M¿S KRYPTOR compact REACT, REF: 89986, used with B¿R¿A¿H¿M¿S PlGF Plus KRYPTOR, REF: 859075N, and run on the B¿R¿A¿H¿M¿S KRYPTOR compact PLUS analyzers. in vitro diagnostic test for Placental Growth Factor
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1789-2025·2025-05-28
SmartPath to dStream 3.0T Medical Device Recall for Software Error
Philips is recalling the SmartPath to dStream 3.0T medical device due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. This could affect image interpretation accuracy.
Product
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0601-2025·2024-12-11
GE Healthcare Optima 520 CT systems recalled for image rotation
GE Healthcare recalled 11 Optima 520 CT systems that produce progressively rotated scan images in helical, cine, and cardiac modes, potentially affecting diagnostic accuracy.
Product
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0609-2025·2024-12-11
GE Healthcare Revolution Frontier CT systems may produce rotated images during scans
GE Healthcare Revolution Frontier CT systems can produce progressively rotated images during helical, cine, and cardiac scans. The rotation can reach up to 56 degrees and may require repeat scans.
Product
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2734-2024·2024-09-04
Electrocardiograph Recall: CARDIOVIT AT-180 May Produce Signal Artifacts
Schiller is recalling CARDIOVIT AT-180 electrocardiographs due to potential high-frequency signal artifacts during ECG acquisition that may affect diagnostic accuracy. 1,084 units are affected worldwide.
Product
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1003-2024·2024-02-14
Siemens Atellica CH Immunoglobulin M Reagent Quality Control Bias
Siemens is recalling 7,075 units of its Total Immunoglobulin M diagnostic reagent due to potential negative bias in quality control and patient sample results. This could affect the accuracy of test results.
Product
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0314-2024·2023-11-22
Blood culture kit recalled due to expired internal components
Medline's blood culture kit is being recalled because components inside the kit have expired before the kit's stated expiration date. This could affect the kit's ability to function properly.
Product
BLOOD CULTURE KIT, REF DYNDH1647B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0588-2022·2022-02-16
Diagnostic Quality Control Microorganism Set Fails Gentamicin Susceptibility Specifications
Microbiologics Inc is recalling 139 units of KWIK-STIK AST-GP QC microorganism sets due to incorrect susceptibility test results. The products failed gentamicin synergy specifications and could affect the accuracy of laboratory diagnostic testing.
Product
QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0452-2022·2022-01-12
Biomeme SARS-CoV-2 Test Instructions Recall: Incorrect Buffer Shelf-Life
Biomeme, Inc. is recalling instructions for the SARS-CoV-2 Real Time RT-PCR Test because shelf-life guidance for resuspended RPC Buffer is incorrect. Instructions specify one week stability, but the buffer is only stable for two days at room temperature.
Product
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0139-2022·2021-10-27
GE SIGNA Artist MRI System May Produce Incomplete Image Scans
GE Healthcare recalls 18 SIGNA Artist MRI systems with a software defect that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
Product
SIGNA Artist nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-1749-2017·2017-04-12
Siemens ADVIA Centaur BR Assay Recalled for Potential Syphilis Assay Interference
Siemens is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay, which may affect test accuracy.
Product
Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centau
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2720-2014·2014-10-08
Siemens Dimension Vista CHEM 1 CAL Recall for Magnesium Calibration Error
Siemens is recalling Dimension Vista CHEM 1 CAL lot 3GM081 because it causes under-recovery of Magnesium in patient and QC samples.
Product
Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0733-2014·2014-01-22
Vital Diagnostics Recalls Eon Calcium Reagent Due to High Positive Bias
Vital Diagnostics, Inc. is recalling 213 units of Eon Calcium Reagent because high positive calcium bias was observed in plasma samples compared to serum results.
Product
Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1997-2013·2013-08-28
Beckman Coulter Recalls Hemoccult ICT Fecal Occult Blood Test Kits
Beckman Coulter is recalling 68,116 Hemoccult ICT units due to increased sensitivity at borderline positive levels, which may cause false positives.
Product
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
Category
Medical Device
Distribution
0 states