The Recall Desk

Hazard

Allergy Testing 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
2025-11-19

Of the 3 allergy testing 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 allergy testing 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-0492-2026·2025-11-19

    Allergy IgE universal kits recalled over barcodes misordering tubes in wedges

    Siemens Healthcare Diagnostics is recalling 2,802 units of the 3gAllergy Specific IgE Universal Kit because barcode orientation causes the instrument to misread tube positions.

    Product
    3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0493-2026·2025-11-19

    Food allergen panels recalled over barcodes causing wrong tube scanning order

    Siemens Healthcare Diagnostics is recalling 28 units of Food Panel 3 Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.

    Product
    Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2026·2025-11-19

    Oak mix allergen tests recalled over barcode orientation misreading tube positions

    Siemens Healthcare Diagnostics is recalling 34 units of IMMULITE 2000 Oak Mix Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.

    Product
    IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
    Category
    Medical Device
    Distribution
    Distributed nationwide