The Recall Desk

Hazard

Unvalidated Test recalls

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

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2022-04-13

Of the 1 unvalidated test 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 unvalidated test 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.

1–1 of 1

  • HighFDA (Devices)·Z-0892-2022·2022-04-13

    Unauthorized SARS-CoV-2 Antigen Tests recalled for lack of FDA clearance

    WHPM Inc. is recalling approximately 535,755 First SIGN SARS-CoV-2 Antigen Tests distributed in California, Florida, Louisiana, Massachusetts, and Texas. The tests were sold without FDA Emergency Use Authorization or clearance.

    Product
    First SIGN SARS-CoV-2 Antigen Test
    Category
    Medical Device
    Distribution
    5 states