The Recall Desk

Hazard

Unverified Diagnostic 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
1
Most recent
2024-10-09

Of the 2 unverified diagnostic recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) 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 unverified diagnostic 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

  • ModerateFDA (Devices)·Z-3307-2024·2024-10-09

    DVOT SARS-CoV-2 and Influenza Antigen Test Kits lack FDA authorization

    The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.

    Product
    DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0944-2022·2022-05-11

    COVID-19 Rapid Test Kits Recalled for Lacking FDA Authorization

    SML Distribution is recalling 209,450 units of Skippack COVID-19 rapid test kits that were distributed without FDA authorization or clearance. The kits were distributed nationwide across Alabama, Florida, Georgia, Missouri, New York, Texas, and Wyoming.

    Product
    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
    Category
    Medical Device
    Distribution
    Distributed nationwide