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3gAllergy Specific IgE Universal Kit recallZ-0492-2026 · Siemens Healthcare Diagnostics, Inc. · initiated Oct 6, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-0492-2026
Status
Open, Classified
Initiated by the company
Oct 6, 2025
Posted by the FDA
Nov 13, 2025
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
2802 units (OUS only)
Product code
DHB
FDA submissions
K101572
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 description

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;

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under K101572 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97819).

Sources and updates

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