Siemens Healthcare Diagnostics, Inc. recalls 3gAllergy Specific IgE Universal Kit

Recalling company

Siemens Healthcare Diagnostics, Inc.

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;

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Oct 6, 2025

Reported

Nov 19, 2025

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.

Status

Ongoing

Quantity

2802 units (OUS only)

Lot / codes

Siemens Material Number (SMN): 10380875; Model/Catalog: L2KUN6; UDI-DI: 00630414962269; Lot number: 169, 170, 171, 172;

Company location

East Walpole, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-0492-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0492-2026 in the FDA Enforcement Report. Also see FDA recall press releases.