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

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.

Details from the source

Reason for recall: 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. 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., Quantity: 34 units (1 US, 33 OUS) Lot/code info: Siemens Material Number (SMN): 10386105; Model/Catalog: T77L2; UDI-DI: 00630414965970; Lot number: 627;

UPC codes

00630414965970

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.