FDA Device recall Z-0493-2026
Food Panel 3 Specific Allergen
- FDA Device
- Class II
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class II recall of Food Panel 3 Specific Allergen by Siemens Healthcare Diagnostics, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0493-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-06 |
| Published | 2025-11-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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.
Identifiers
| code_info | Siemens Material Number (SMN): 10385891; Model/Catalog: FP3L4; UDI-DI: 00630414960418; Lot number: 629; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0493-2026%22
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