FDA DeviceNov 19, 2025Class II

IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;

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.

From the FDA notice · Read the official notice ↗ · All Siemens recalls

What to do

The agency's notice has the remedy and who to contact.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected: 34 units (1 US, 33 OUS)
Illnesses reported: None reported
Manufactured in: 333 Coney St, East Walpole, MA, United States
Classification: Class II
Recall number: Z-0491-2026

In the FDA's words

Description: IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6; 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. Siemens Material Number (SMN): 10386105; Model/Catalog: T77L2; UDI-DI: 00630414965970; Lot number: 627; Distribution: Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Latvia, Macedonia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Portugal, Romania, Russian Fed., Serbia, Slovakia, Spain, Sweden, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay. Affected quantity: 34 units (1 US, 33 OUS)
Hazard: 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.

3 products in this recall

Siemens IMMULITE allergen test kits recalled for barcode scanning error

Siemens is recalling three IMMULITE allergen test products used with IMMULITE 2000 and IMMULITE 2000 XPi instruments. When paired with a Zebra barcode scanner, the barcode orientation can cause the instrument to misread the position of tubes in the allergen holder wedge. No injuries have been reported. The recall covers 2,864 units, with only one unit distributed in the US, and the rest sent to other countries.

The agency lists each product separately. Check every one you might have.

IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6; (this page)
Z-0491-2026 · 34 units (1 US, 33 OUS)
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); S…
Z-0492-2026 · 2802 units (OUS only)
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Z-0493-2026 · 28 units (OUS only)