The Recall Desk

Hazard

Sample Carryover recalls

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

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2023-05-24

Of the 5 sample carryover 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 sample carryover 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.

1–5 of 5

  • HighFDA (Devices)·Z-1598-2023·2023-05-24

    Urine Microscopy Analyzer Software Defect May Prevent Carryover Detection

    Beckman Coulter is recalling the DxU 840m Iris Urine Microscopy Analyzer due to a software issue where a carryover detection flag may fail to display, potentially resulting in undetected sample contamination and incorrect test results.

    Product
    DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1599-2023·2023-05-24

    Urine Analysis Diagnostic Device Software Issue Prevents Carryover Detection

    Beckman Coulter is recalling UA WIN 10 diagnostic kits because an optional software flag for detecting sample carryover was enabled but not displayed, preventing proper investigation of potential test contamination.

    Product
    UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1015-2022·2022-05-04

    IMMULITE 2000 hCG diagnostic systems recalled for falsely elevated results

    Siemens Healthcare is recalling IMMULITE 2000 hCG diagnostic systems due to potential sample carryover that could produce falsely elevated hCG test results.

    Product
    IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0032-2022·2021-10-13

    Beckman Coulter Troponin I Reagent Packs Recalled Due to Sample Contamination

    Beckman Coulter is recalling 293,640 Access hsTnI High Sensitivity Troponin I reagent packs due to sample carryover contamination occurring with very high concentration samples, potentially affecting test accuracy.

    Product
    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2049-2017·2017-05-17

    Roche Diagnostics Recalls Sample Probes for Corrosion-Related Liquid Level Detection Issues

    Roche Diagnostics is recalling 3,946 sample probes for cobas analyzers because corrosion on electrical contacts can disrupt liquid level detection, potentially causing sample carryover.

    Product
    Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immun
    Category
    Medical Device
    Distribution
    Distributed nationwide