# FDA recall Z-0491-2026

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2025-10-06.

## Product

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

## 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.

## Key facts

- **Recall number:** Z-0491-2026
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-06
- **Report date:** 2025-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0491-2026

## Citation

> AI Analytics. FDA recall Z-0491-2026. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-0491-2026. Source: US FDA. Licensed CC0.

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