The Recall Desk

Hazard

Insufficient Evidence 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
2021-09-29

Of the 1 insufficient evidence 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 insufficient evidence 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-2508-2021·2021-09-29

    COVID-19 antibody test assay recalled due to insufficient validation evidence

    Beckman Coulter is recalling Access SARS-CoV-2 IgG test kits nationwide due to insufficient evidence in the FDA authorization submission. The test validation may be inadequate for accurate COVID-19 antibody detection.

    Product
    Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
    Category
    Medical Device
    Distribution
    Distributed nationwide