IMMULITE 2000 Allergen Holder Wedges Recalled for Barcode Scanning Error

Agency Publication Date: November 13, 2025

Summary

Siemens Healthcare Diagnostics is recalling 2,864 units of IMMULITE 2000 Oak Mix Specific Allergen, 3gAllergy Specific IgE Universal Kits, and Food Panel 3 Specific Allergen. These products have an incorrect barcode orientation that causes IMMULITE 2000 and IMMULITE 2000 XPi instruments using Zebra scanners to misidentify the position of tubes within the holder. This recall affects various lots manufactured in the United States and distributed worldwide.

Risk

The incorrect barcode orientation causes the scanning instrument to recognize tubes in the wrong order. This can lead to the instrument processing samples incorrectly or generating diagnostic test results that do not correspond to the correct patient allergen, potentially impacting medical decisions.

What You Should Do

This recall involves IMMULITE 2000 Oak Mix Specific Allergen, 3gAllergy Specific IgE Universal Kits, and Food Panel 3 Specific Allergen used with IMMULITE 2000 and 2000 XPi instruments.
Identify if your laboratory inventory is affected by checking the Siemens Material Numbers (SMN) and lot numbers on the product packaging. Affected codes include SMN 10386105 (Lot 627), SMN 10380875 (Lots 169, 170, 171, 172), and SMN 10385891 (Lot 629). See the Affected Products section below for the full list of affected codes.
Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: IMMULITE 2000 Oak Mix Specific Allergen

Model / REF:

L2KUN6

T77L2

10386105

Lot Numbers:

627

UDI:

00630414965970

Recall #: Z-0491-2026; Quantity: 34 units (1 US, 33 OUS)

Product: 3gAllergy Specific IgE Universal Kit

Variants: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2)

Model / REF:

L2KUN6

10380875

Lot Numbers:

169

170

171

172

UDI:

00630414962269

Recall #: Z-0492-2026; Quantity: 2802 units (OUS only)

Product: Food Panel 3 Specific Allergen

Model / REF:

FP3L4

10385891

Lot Numbers:

629

UDI:

00630414960418

Recall #: Z-0493-2026; Quantity: 28 units (OUS only)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97819

Status: Active

Manufacturer: Siemens Healthcare Diagnostics, Inc.

Sold By: Siemens Healthcare Diagnostics; Authorized Medical Device Distributors

Manufactured In: United States

Units Affected: 3 products (34 units (1 US, 33 OUS); 2802 units (OUS only); 28 units (OUS only))

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall involves IMMULITE 2000 Oak Mix Specific Allergen, 3gAllergy Specific IgE Universal Kits, and Food Panel 3 Specific Allergen used with IMMULITE 2000 and 2000 XPi instruments.

Identify if your laboratory inventory is affected by checking the Siemens Material Numbers (SMN) and lot numbers on the product packaging. Affected codes include SMN 10386105 (Lot 627), SMN 10380875 (Lots 169, 170, 171, 172), and SMN 10385891 (Lot 629). See the Affected Products section below for the full list of affected codes.

Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Affected Products

Product: IMMULITE 2000 Oak Mix Specific Allergen

Model / REF:

L2KUN6

T77L2

10386105

Lot Numbers:

627

UDI:

00630414965970

Recall #: Z-0491-2026; Quantity: 34 units (1 US, 33 OUS)

Product: 3gAllergy Specific IgE Universal Kit

Variants: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2)

Model / REF:

L2KUN6

10380875

Lot Numbers:

169

170

171

172

UDI:

00630414962269

Recall #: Z-0492-2026; Quantity: 2802 units (OUS only)

Product: Food Panel 3 Specific Allergen

Model / REF:

FP3L4

10385891

Lot Numbers:

629

UDI:

00630414960418

Recall #: Z-0493-2026; Quantity: 28 units (OUS only)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97819

Status: Active

Manufacturer: Siemens Healthcare Diagnostics, Inc.

Sold By: Siemens Healthcare Diagnostics; Authorized Medical Device Distributors

Manufactured In: United States

Units Affected: 3 products (34 units (1 US, 33 OUS); 2802 units (OUS only); 28 units (OUS only))

Distributed To: Nationwide