IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Summary
The FDA issued a Class II for IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 1038610 by Siemens Healthcare Diagnostics, Inc.. Reason: The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / I.
Details
Source
Device Recall
External ID
Z-0491-2026
Action Date
2025-11-19
Status
Ongoing
Category
device
Product Description
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Lot/Code Info: Siemens Material Number (SMN): 10386105; Model/Catalog: T77L2; UDI-DI: 00630414965970; Lot number: 627;
Quantity Affected: 34 units (1 US, 33 OUS)
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., Serbia, Slovakia, Spain, Sweden, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-06
Company
East Walpole, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0491-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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