The Recall Desk

FDA (Devices) recall action 97819

Siemens Healthcare Diagnostics, Inc. recalled 3 products on 2025-11-19

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2025-11-19
Critical
0
Units
2,830

Why these products were recalled

The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··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
    Distribution
    1 state
  • HighFDA (Devices)··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
    Distribution
    1 state
  • HighFDA (Devices)··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
    Distribution
    1 state