The Recall Desk

Hazard

Incorrect Results recalls

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

What the numbers show

Total
88
Critical
4
Severe
2
Most recent
2026-01-21

Of the 88 incorrect results recalls we have scored against our rubric, 4 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (2%) 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 incorrect results 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.

26–50 of 88

  • ModerateFDA (Devices)·Z-1797-2020·2020-05-06

    Siemens Atellica CH 930 Analyzer Recall for Software Defect

    Siemens is recalling Atellica CH 930 Analyzers with specific software versions due to a defect that may cause incorrect test results.

    Product
    Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2020·2020-04-15

    Beckman Coulter MicroScan PROMPT Inoculation System-D Recalled for Incorrect Wands

    Beckman Coulter is recalling 3,472 units of the MicroScan PROMPT Inoculation System-D because they contain incorrect prompt wands, which may cause inaccurate antimicrobial susceptibility test results.

    Product
    Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0581-2020·2019-12-04

    Siemens Atellica CH 930 Analyzer Recalled for Calibration Error

    Siemens Healthcare Diagnostics is recalling 1,432 Atellica CH 930 Analyzers due to a potential calibration error that may cause results to be five times higher than expected.

    Product
    Atellica CH 930 Analyzer
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-0575-2020·2019-12-04

    Abbott Recalls Alinity c Carbon Dioxide Reagent Kits Due to CO2 Absorption

    Abbott is recalling Alinity c Carbon Dioxide Reagent Kits because atmospheric carbon dioxide can be absorbed into the reagent, potentially causing incorrect test results.

    Product
    Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0044-2020·2019-10-16

    Roche AssayTip/AssayCup Tray Recall for Abnormal Internal Structure

    Roche Diagnostics is recalling AssayTip/AssayCup Trays used on the cobas e 801 module due to abnormal internal structure that may lead to incorrect patient results.

    Product
    AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2019·2019-09-04

    Abbott Recalls Alinity ci Series System Control Modules Due to Software Error

    Abbott is recalling Alinity ci series System Control Modules because a software issue may cause incorrect test results after a system stop.

    Product
    Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2019·2019-05-01

    Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Software Error

    Ortho-Clinical Diagnostics is recalling 80 VITROS XT 7600 Integrated Systems because a software error may cause incorrect test results without alerting the user.

    Product
    VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2019·2019-04-17

    Abbott ARCHITECT c16000 Processing Module Recalled for Potential Incorrect Results

    Abbott Laboratories is recalling 1,666 ARCHITECT c16000 Processing Modules worldwide because unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potenti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2019·2019-04-17

    Abbott ARCHITECT c8000 Processing Module Recall for Potential Incorrect Results

    Abbott is recalling 3,794 ARCHITECT c8000 Processing Modules because unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2019·2019-04-17

    Abbott ARCHITECT c4000 Processing Module Recalled for Potential Incorrect Results

    Abbott Laboratories is recalling 3,675 ARCHITECT c4000 Processing Modules because specific unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2019·2019-04-10

    Beckman Coulter UniCel DxI 600 and 800 Systems Recalled for Software Error

    Beckman Coulter is recalling UniCel DxI 600 and 800 systems due to a software scheduling error that can cause incorrect immunoassay results.

    Product
    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1078-2019·2019-04-10

    Beckman Coulter Recalls UniCel DxC Clinical Systems Due to Software Error

    Beckman Coulter is recalling UniCel DxC clinical systems where a software scheduling error can cause sample mishandling and generate incorrect test results.

    Product
    UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A6
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0515-2019·2018-12-05

    Eurotrol HemoTrol Level 3 Recalled Due to Microbial Contamination

    Eurotrol Inc. is recalling HemoTrol Level 3 hematology quality control mixtures because microbial contamination causes incorrect, lower-than-assigned measurement results.

    Product
    HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0189-2019·2018-10-24

    Siemens Recalls Atellica Sample Handler Prime Software Due to Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Prime software versions 1.13 and lower due to five identified behavioral issues affecting diagnostic testing.

    Product
    Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0191-2019·2018-10-24

    Siemens Atellica Sample Handler Software Recall for Diagnostic Errors

    Siemens Healthcare Diagnostics is recalling Atellica Sample Handler software versions 1.13 and lower due to five behavioral issues that may cause incorrect sample processing or result reporting.

    Product
    Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0190-2019·2018-10-24

    Siemens Atellica Sample Handler Software Recall for Diagnostic Errors

    Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Connect software versions 1.13 and lower due to five behavioral issues that may cause incorrect sample processing or result reporting.

    Product
    Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0194-2019·2018-10-24

    Siemens Atellica Analyzer Software Recall for Diagnostic Errors

    Siemens is recalling Atellica Solution software version 1.13 and lower due to five behavioral issues that may cause incorrect test results or sample handling errors.

    Product
    Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2882-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Error

    Ortho Kinematics is recalling Vertebral Motion Analyzer (VMA) software version 2.3.252 due to a software bug that caused errors in released testing results.

    Product
    Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2596-2018·2018-08-08

    QIAGEN Recalls EZ1 DSP Virus Kit Due to Underfilled Reagent Wells

    QIAGEN is recalling 287 units of the EZ1 DSP Virus Kit (48) because underfilled reagent wells could lead to incorrect diagnostic results.

    Product
    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2391-2018·2018-07-18

    Ekla Recalls NOVAPLUS Pregnancy Test Kits Due to Incorrect Results

    Ekla Corporation is recalling 295 NOVAPLUS Pregnancy Cassette Devices because they may provide incorrect hCG results. The affected kits were distributed in California, Illinois, Minnesota, and Rhode Island.

    Product
    NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1643-2018·2018-05-16

    Beckman Coulter iChemVELOCITY Urine Chemistry System Recall for Incorrect Settings

    Beckman Coulter is recalling 2,225 iChemVELOCITY Urine Chemistry Systems because incorrect settings may cause false low results or incorrect color reporting.

    Product
    BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1183-2018·2018-04-04

    Quidel Recalls Sofia 2 Analyzers Due to Calibration Error

    Quidel is recalling 482 Sofia 2 Analyzers because a manufacturing error may cause calibration failure or incorrect test results.

    Product
    Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0675-2018·2018-02-28

    Roche Cobas 8000 Modular Series Software Recall for Incorrect Results Risk

    Roche Diagnostics is recalling 399 Cobas 8000 Modular Series systems due to a software failure that may reset settings to defaults, creating a risk of incorrect test results.

    Product
    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0493-2018·2018-02-07

    Horiba Medical Recalls ABX PENTRA Reagent Cups Due to Fit Issues

    Horiba Medical is recalling ABX PENTRA reagent cups that may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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