The Recall Desk

Hazard

Delayed Test Results 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
2025-03-26

Of the 5 delayed test results 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 delayed test 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.

1–5 of 5

  • ModerateFDA (Devices)·Z-1386-2025·2025-03-26

    Access 2 Immunoassay Analyzer motor alignment issue may delay results

    Beckman Coulter is recalling Access 2 Immunoassay Analyzers due to sample motor misalignment that may delay patient test result reporting. The recall affects 873 units distributed worldwide.

    Product
    Access 2 Immunoassay Analyzer, Catalog Number 81600N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2025·2025-01-01

    Medical Device Recall: BD FACSLyric Flow Cytometer Power Supply Failure Risk

    BD is recalling power supply modules in FACSLyric flow cytometers that may fail to power on or remain powered. Failure could expose lab staff to fumes and cause patient specimen loss or delayed test results.

    Product
    FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2025·2024-10-09

    BD FACSDuet Sample Preparation System software defect causes inaccurate specimen volumes

    The BD FACSDuet sample preparation system may dispense specimen volumes that are 3% to 20% higher in one tube versus another, leading to inaccurate blood counts, delayed test results, and potential additional blood collection. The defect affects 130 systems distributed across the US and internationally.

    Product
    BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1555-2023·2023-05-10

    VITROS XT 7600 Analyzer Pack Opener May Not Remove Reagent Pack Caps

    The MicroTip Pack Opener Assembly in VITROS XT 7600 laboratory analyzers may fail to properly remove or replace reagent pack caps, potentially causing unusable packs and delayed test results. Approximately 2,001 affected units were distributed nationwide and internationally.

    Product
    VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0220-2023·2022-11-16

    Diagnostic Calibrator Kit Recalled for Software Defect Affecting System Calibration

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.

    Product
    VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7
    Category
    Medical Device
    Distribution
    Distributed nationwide