Z-0491-2026Class II

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

Name: Z-0491-2026 IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2025-10-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-10-06 / Open, Classified / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6 on 2025-10-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0491-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-06
Posted: 2025-11-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Product code: DHB System, Test, Radioallergosorbent (Rast) Immunological
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On October 6, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer Actions Perform the instructions provided below: " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " Discontinue use of and discard IMMULITE 2000 Oak Mix Specific Allergen Lot 627. " Review your inventory of the product to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 7 days. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution The issue is resolved with the next available lot of IMMULITE 2000 Oak Mix Specific Allergen. It is anticipated that the replacement lot will be available by mid-November 2025. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Custom
Quantity in commerce: 34 units (1 US, 33 OUS)
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.
Product codes and lots: Siemens Material Number (SMN): 10386105; Model/Catalog: T77L2; UDI-DI: 00630414965970; Lot number: 627;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0491-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0491-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0492-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0493-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13

Product code DHB

K021206Class IIImmulite 2000 Specific AllergensDiagnostic Products Corp. / cleared 2002-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)