The Recall Desk

Hazard

Erroneous Lab Results recalls

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2024-10-16

Of the 2 erroneous lab 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 erroneous lab 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.

1–2 of 2

  • HighFDA (Devices)·Z-0025-2025·2024-10-16

    Medical Analyzer Software Flaw Allows Use of Expired Calibrator

    Beckman Coulter DxI 9000 immunoassay analyzers with software version 1.16.2 and prior can process orders using expired calibration material, potentially producing incorrect patient laboratory test results.

    Product
    Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1131-2013·2013-04-24

    Heritage Labs Path Study Extra Supplies Kit Recalled for Contamination

    Heritage Labs is recalling 25 Path Study Extra Supplies Kits because they contain blood collection tubes with a Lithium Heparin contaminant that could cause erroneous lab results.

    Product
    Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for dr
    Category
    Medical Device
    Distribution
    Distributed nationwide