Product Wiki · Recalls · U.S. FDA — Device Enforcement

Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4; — recall Z-0493-2026

U.S. FDA — Device Enforcement · United States · 2025-10-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0493-2026
Date of alert
2025-10-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10385891
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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