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.

251–275 of 397

  • HighFDA (Devices)·Z-1268-2018·2018-04-04

    Roche cobas e 601 Immunoassay Analyzer Recalled for Questionable Results

    Roche Diagnostics is recalling cobas e 601 Immunoassay Analyzers because complaints were received regarding questionable results caused by the use of 13 sample tubes without tube adapters.

    Product
    c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2018·2018-04-04

    Siemens Dimension Vista LOCI 8 Calibrator Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling the Dimension Vista LOCI 8 Calibrator due to increased failed calibration events and negative bias in Estradiol assays.

    Product
    Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1070-2018·2018-03-21

    Stanbio Recalls RaPET RF Latex Reagent Due to False Positive Test Results

    Stanbio Laboratory is recalling RaPET RF Latex Reagent because it causes all patient serum samples to yield weakly positive test results.

    Product
    RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2018·2018-03-14

    Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results

    Abbott is recalling ARCHITECT c4000 Cuvette Segments because a detached post can cause falsely depressed patient results in adjacent cuvettes.

    Product
    ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2018·2018-02-28

    Fujifilm Recalls Mammography Software Due to Potential Image Overwrite Error

    Fujifilm is recalling 71 units of the Fuji Computed Radiography Mammography Suite because a software error may cause new images to overwrite previous ones in the hospital system.

    Product
    Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0494-2018·2018-02-07

    Horiba Medical Recalls ABX PENTRA Reagent Cups for Fit Issues

    Horiba Medical is recalling 15 mL reagent cups for ABX PENTRA analyzers because they may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2729-2017·2017-07-19

    Natus Neurology Recalls Elite 5 MHz Vascular Probes Due to Noise Issues

    Natus Neurology is recalling 2,335 Elite 5 MHz Vascular Probes because excessive background noise may mask heart rate and blood flow signals.

    Product
    Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2656-2017·2017-07-12

    JAS Diagnostics Recalls Drew Scientific DREW 3-PAC Reagent Kits

    JAS Diagnostics Inc. is recalling 14,064 units of Drew Scientific DREW 3-PAC Reagent Kits because they may result in elevated platelet backgrounds during routine startup checks.

    Product
    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2084-2017·2017-05-24

    Beckman Coulter Recalls Salicylate Reagent Due to Drug Interference

    Beckman Coulter is recalling Salicylate Reagent (Catalog No. 378194) because specific drugs can cause false low results in salicylate testing.

    Product
    Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1875-2017·2017-05-03

    Siemens ACUSON S Family Ultrasound Systems Recalled for Image Display Defects

    Siemens is recalling 2,045 ACUSON S Family ultrasound systems because the 18L6 HD transducer may display a triple image or a dark band, potentially affecting diagnostic accuracy.

    Product
    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1420-2017·2017-03-15

    Siemens IMMULITE Progesterone Test Kits Recalled for DHEA-S Interference

    Siemens is recalling IMMULITE Progesterone test kits because DHEA-S causes falsely elevated results, potentially affecting diagnosis.

    Product
    IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1418-2017·2017-03-15

    Siemens ADVIA Centaur Progesterone Test Recalled for DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1419-2017·2017-03-15

    Siemens Progesterone Test Recalled Due to DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista LOCI Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centau
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1385-2017·2017-03-08

    Merge Healthcare Recalls Unity PACS Software Due to Image Error

    Merge Healthcare is recalling Unity PACS software versions 11.0 and 11.0.1 because the software fails to add the correct tomo image.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1119-2017·2017-02-08

    Siemens Recalls IMMULITE PSA Kits Due to Negative Bias

    Siemens Healthcare Diagnostics is recalling IMMULITE PSA kits worldwide because patient samples show an average negative bias of approximately -22%.

    Product
    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in huma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2017·2017-02-01

    Roche Tina-Quant CRP Latex Test System Recalled for Low Results

    Roche is recalling Tina-Quant CRP Latex High Sensitive test kits due to potential under-recovery of results, which may lead to incorrect cardiovascular risk assessments.

    Product
    Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical che
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0977-2017·2017-01-25

    BioMerieux NucliSENS magnetic extraction reagents recalled for performance drift

    BioMerieux SA is recalling NucliSENS magnetic extraction reagents because a performance drift was observed in BK virus testing for certain silica batches.

    Product
    NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1013-2017·2017-01-18

    Beckman Coulter Recalls UniCel DxH 800 Cellular Analysis System

    Beckman Coulter is recalling the UniCel DxH 800 Cellular Analysis System because it may fail to detect blasts in some blood samples.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2017·2017-01-11

    Merge Unity PACS Software Recalled for Incorrect Mammogram Image Association

    Merge Healthcare is recalling Unity PACS software version 11.0 because it may fail to associate the correct mammogram image when two images exist for the same view.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS software.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0652-2017·2016-11-30

    Siemens Dimension Vista Chemistry 1 Calibrator Recall for Low Calcium Recovery

    Siemens is recalling Dimension Vista Chemistry 1 Calibrators (lots 5GM081 and 5GM082) because they may cause discrepant low calcium recovery in quality control and patient samples.

    Product
    Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2017·2016-11-23

    Siemens Recalls Advia Chemistry Calibrator Due to Bilirubin Bias

    Siemens is recalling Advia Chemistry Calibrators because incorrect values may cause a 41% positive bias in Direct Bilirubin patient results.

    Product
    Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CRE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2017·2016-11-23

    Siemens Vitamin D Total Assay Recalled for Plasma Sample Bias

    Siemens Healthcare Diagnostics is recalling Vitamin D Total Assay kits due to a negative bias when testing plasma samples instead of serum.

    Product
    Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0314-2017·2016-11-02

    BBI Solutions Recalls SimpliRED D-Dimer Assay Kits Due to Performance Issues

    BBI Solutions is recalling SimpliRED D-Dimer assay kits because stability testing showed reduced sensitivity, which may cause false negative results and affect clinical decisions.

    Product
    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood
    Category
    Medical Device
    Distribution
    2 states