The Recall Desk

Hazard

Incorrect Result recalls

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

What the numbers show

Total
17
Critical
0
Severe
1
Most recent
2024-12-18

Of the 17 incorrect result recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (6%) 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 result 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.

1–17 of 17

  • HighFDA (Devices)·Z-0677-2025·2024-12-18

    DiaSorin LIAISON Device Recall: Loose Caps May Cause Incorrect Patient Test Results

    DiaSorin Inc. is recalling over 21,900 LIAISON Q.S.E.T. Device Plus units worldwide due to loose caps that may leak buffer, potentially resulting in incorrect stool sample test results.

    Product
    DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0185-2020·2019-10-30

    Life Technologies Recalls Torrent Suite Dx Software for Incorrect Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for specific clinical variants.

    Product
    Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0186-2020·2019-10-30

    Life Technologies Recalls Torrent Suite Dx Software Due to Incorrect Positive Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.

    Product
    Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2290-2019·2019-08-28

    Siemens IMMULITE 2000 Progesterone Test Recalled for Potential Low Results

    Siemens is recalling IMMULITE 2000 Progesterone tests because some samples may produce falsely low results, potentially leading to unnecessary medication.

    Product
    IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2019·2019-08-28

    Siemens IMMULITE 1000 Progesterone Test Recall for Low Results

    Siemens is recalling IMMULITE 1000 Progesterone tests because they may produce falsely low results, potentially leading to unnecessary progesterone supplementation.

    Product
    IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2019·2019-05-29

    Polymer Technology Systems Recalls Lipid Panel Test Strips Due to Fit Issues

    Polymer Technology Systems is recalling Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect results.

    Product
    Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2019·2019-05-29

    Polymer Technology Systems Recalls CHOL+HDL+GLU Test Strips

    Polymer Technology Systems is recalling CHOL+HDL+GLU test strips because they may not fit tightly into the optical block, potentially causing incorrect results.

    Product
    CHOL+HDL+GLU test strips, REF 2412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1372-2019·2019-05-29

    Polymer Technology Systems Recalls Lipid Panel Test Strips for Fit Issues

    Polymer Technology Systems is recalling certain Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect test results.

    Product
    Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0192-2019·2018-10-24

    Siemens Atellica IM 1300 Analyzer Software Recall for Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.13 and lower due to five identified behavioral issues affecting reagent locks, barcode reading, and result reporting.

    Product
    Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0079-2019·2018-10-17

    Ortho-Clinical VITROS 5600 System Recalled for Sample Dispensing Defect

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because they may dispense insufficient sample volume without suppressing potentially incorrect results.

    Product
    VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2018·2018-07-18

    Roche Vitamin D Test System Recalled for Falsely Elevated Results

    Roche Diagnostics is recalling the Elecsys Vitamin D total II test system because it may produce falsely elevated, non-reproducible results, potentially leading to incorrect vitamin D dosage adjustments.

    Product
    Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2018·2018-06-20

    Roche Recalls Accu-Chek Inform II Test Strips Due to Potential Errors

    Roche Diabetes Care is recalling Accu-Chek Inform II test strips because they may produce errors or biased results, potentially leading to incorrect user actions.

    Product
    Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2014·2014-09-10

    Siemens EasyLink Informatics System Recall for Potential Result Transmission Errors

    Siemens Healthcare Diagnostics is recalling the EasyLink Informatics System V4.0/V5 because it may release results to the Laboratory Information System that should have been held for manual review.

    Product
    Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2014·2014-06-18

    Alere Triage D-Dimer Test Recalled for Incorrect Manufacturing

    Alere San Diego, Inc. is recalling 373 kits of the Alere Triage D-Dimer Test (Lot W53884B) because they may generate error codes or incorrect results.

    Product
    Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0851-2014·2014-02-05

    Siemens Dimension Vista 500 and 1500 Systems Recalled for Flex Assignment Error

    Siemens is recalling Dimension Vista 500 and 1500 systems with software version 3.5.1 or lower because the system may assign the wrong Flex cartridge to user-defined methods.

    Product
    User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to dupli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2013·2013-07-03

    Roche Recalls CoaguChek XS Meters Due to Potential Test Errors

    Roche is recalling CoaguChek XS System meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.

    Product
    CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2013·2013-01-16

    Horiba Medical Recalls ABX PENTRA ML Software Due to Data Validation Error

    Horiba Medical is recalling ABX PENTRA ML software versions V8.0.x and below, V9.0.1, and V9.0.2 because a rare data management issue may transmit incorrect patient results to the Laboratory Information System.

    Product
    ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
    Category
    Medical Device
    Distribution
    Distributed nationwide