The Recall Desk

Hazard

Mis Identification 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
0
Most recent
2026-08-05

Of the 17 mis identification 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.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all mis identification 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-2822-2026·2026-08-05

    Bar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk

    Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.

    Product
    Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2514-2024·2024-08-14

    Diagnostic Test Kits Recalled for False Vibrio Results With Certain Transport Medium

    BioFire Diagnostics is recalling gastrointestinal diagnostic test kits due to false positive Vibrio results when used with certain transport mediums.

    Product
    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnost
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2022·2022-07-06

    Stryker INFINITY Resect Guide Recalled for Incorrect Color Coding

    Wright Medical is recalling 35 units of the Stryker INFINITY Resect Guide for INBONE Talus (Model #33620254) due to incorrect color coding. The color coding error could lead to misidentification and improper use during ankle surgery.

    Product
    Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0872-2021·2021-10-06

    Althaea Officinalis Homeopathic Pills Recall Due to Failed Identity Testing

    Washington Homeopathic Products is recalling Althaea Officinalis 6X Irritable Bladder Sucrose/Lactose Pills distributed nationwide because test results failed to confirm the product's identity using HPTLC analysis.

    Product
    Althaea Officinalis 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2021·2021-04-14

    Beckman Coulter MicroScan WalkAway-40 Plus Reconditioned Instruments Recalled

    Beckman Coulter is recalling six reconditioned MicroScan WalkAway-40 Plus instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-40 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1370-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-40 plus Instruments

    Beckman Coulter is recalling 16 MicroScan WalkAway-40 plus instruments because a shortened reagent straw may cause reagent dispensing failures, leading to organism misidentification or quality control failures.

    Product
    MicroScan WalkAway-40 plus Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1373-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-96 plus Reconditioned Instruments

    Beckman Coulter is recalling nine MicroScan WalkAway-96 plus Reconditioned Instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-96 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0914-2020·2020-02-05

    Beckman Coulter iQ200 Urine Analyzer Recalled for Duplicate Specimen ID Errors

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may report duplicate Specimen IDs with different patient results.

    Product
    iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis pro
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1414-2017·2017-03-15

    Becton Dickinson Recalls EpiCenter Plus Software Version 6.20A

    Becton Dickinson is recalling EpiCenter Plus Microbiology Data Management System software version 6.20A because outdated translation tables may cause mis-identification of organisms.

    Product
    EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter sys
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1578-2016·2016-05-04

    Roche IT3800 Hand-Held Barcode Scanner Recalled for Mis-Identification

    Roche Molecular Systems is recalling 6,939 IT3800 hand-held barcode scanners because they mis-identified sample barcodes when used with the COBAS AmpliPrep instrument.

    Product
    Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0106-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1245 blood gas analyzers because users may enter wrong patient IDs, potentially leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1265 blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab and RAPIDPoint blood gas analyzers because users can enter wrong patient IDs, risking sample misidentification.

    Product
    Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2013·2013-04-24

    Roche Recalls CoaguChek XS Pro Meters Due to Barcode Reading Errors

    Roche is recalling CoaguChek XS Pro meters and Accu-Chek Inform II barcode scanners because they may incorrectly decode patient identification barcodes.

    Product
    CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2013·2013-04-24

    Roche Recalls Accu-Chek Inform II Barcode Scanners Due to Decoding Errors

    Roche Diagnostics is recalling Accu-Chek Inform II and CoaguChek XS Pro barcode scanners because they may intermittently misread patient identification barcodes.

    Product
    ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0699-2013·2013-01-30

    Becton Dickinson Recalls BBL Crystal Enteric/Nonfermenter ID Kits

    Becton Dickinson is recalling BBL Crystal Enteric/Nonfermenter ID Kits because reversed reagent positions may cause bacteria misidentification.

    Product
    Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram
    Category
    Medical Device
    Distribution
    14 states