The Recall Desk

Hazard

Reagent Lot recalls

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

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2025-09-10

Of the 3 reagent lot 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 reagent lot 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.

1–3 of 3

  • HighFDA (Devices)·Z-2515-2025·2025-09-10

    Toxoplasma IgM assay kits recalled over risk of false positive results

    Platelia Toxo IgM kits, catalog number 26211, lot 4L0054, are recalled because of a risk of false positive results that could lead to unnecessary medical treatment. 35 kits are affected.

    Product
    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2336-2025·2025-08-27

    Estrone diagnostic kits recalled over rare falsely high or low results

    Estrone RIA kits, catalog number DSL8700, are recalled because certain lots may rarely give falsely high or falsely low patient results. 279 units are affected.

    Product
    Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2322-2025·2025-08-20

    Thyroglobulin assay reagent recalled after lot generated erroneously high patient results

    Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.

    Product
    Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
    Category
    Medical Device
    Distribution
    Distributed nationwide