Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;

Company / brand

Siemens Healthcare Diagnostics, Inc.

Product

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

Reason / 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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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.

Recall initiated

2025-10-06

Code info

Siemens Material Number (SMN): 10386105; Model/Catalog: T77L2; UDI-DI: 00630414965970; Lot number: 627;

Product quantity

34 units (1 US, 33 OUS)

Voluntary mandated

Voluntary: Firm initiated

City

East Walpole

State

MA

Country

United States

Event id

97819

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