Recall Z-0493-2026— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0493-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-06

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2025-10-06. It names one FDA 510(k) clearance: K021208. Product: Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-10-06
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K021208 — IMMULITE 2000 MIXED ALLERGEN PANELSDiagnostic Products Corp.·cleared 2002-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.