The Recall Desk

Hazard

Misidentification recalls

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

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2026-04-08

Of the 8 misidentification 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 misidentification 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.

1–8 of 8

  • HighFDA (Devices)·Z-1766-2026·2026-04-08

    Oxoid Microbact Listeria kit may identify the incorrect organism

    Oxoid, part of Thermo Fisher Scientific, is recalling one lot of the Microbact 12L Listeria identification kit because it may identify the incorrect organism.

    Product
    OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3247-2024·2024-10-02

    BD Phoenix diagnostic systems may misidentify E. coli in clinical samples

    The BD Phoenix 100 system may misidentify Escherichia coli in clinical samples, potentially leading to misdiagnosis and inappropriate patient treatment. Becton Dickinson is recalling 764 units distributed worldwide.

    Product
    BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2023·2022-12-07

    Diagnostic Kit Recalled for False Positive Bacterial Identification Results

    Accelerate Diagnostics is recalling the Accelerate PhenoTest BC kit due to improperly formulated FISH probes that produce false positive identification results for Staphylococcus aureus and Streptococcus species. Approximately 7,160 kits have been distributed across the United States and internationally.

    Product
    Accelerate PhenoTest BC kit REF 10102018
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0665-2022·2022-03-02

    BD Vacutainer Luer Lok Access Device may shed particles causing false test results

    BD's Vacutainer Luer Lok Access Device may release contaminant particles that can be misidentified as red blood cells in laboratory analysis, potentially leading to false elevated RBC counts.

    Product
    BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2022·2022-02-02

    API ID 32 C Diagnostic Strips Recalled Due to Thermoforming Defect

    Biomerieux is recalling API ID 32 C Strips due to a thermoforming defect that risks misidentification of yeasts or delayed diagnostic results. The recall affects 462 kits in Arizona, Iowa, Kentucky, and New York.

    Product
    API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either autom
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2732-2016·2016-09-14

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Systems

    Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems due to a risk of specimen misidentification when the Primary Identifier is set to Tube Position ID.

    Product
    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0103-2014·2013-11-06

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Sample Misidentification Risk

    Siemens is recalling RAPIDPoint 405 blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2013·2013-08-21

    Veridex CellTracks Analyzer II Recalled for Patient Data Association Error

    Veridex is recalling CellTracks Analyzer II software versions 2.5.1 and below because patient demographics were incorrectly associated with another patient's ID.

    Product
    CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole b
    Category
    Medical Device
    Distribution
    Distributed nationwide