Food Panel 3 Specific Allergen — Class II medical device recall Z-0493-2026
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2025-11-19, distributed nationwide. The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holde
| Recall number | Z-0493-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., East Walpole, MA, United States |
| Recall initiated | 2025-10-06 |
| Classified | 2025-11-13 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CL, CO, CR, CZ, DE, EE, ES, FR, GB, GR, GT, HK, HR, HU, IL, IT, LV, MX, NL, NO, PA, PK, PL, PT, RO, RS, SE, SK, TR, UA, UY |
| Quantity | 28 units |
| Reason classes | undeclared allergen |
| UPC / GTIN / UDI-DI | 00630414960418 |
| Lot numbers | 629 |
| Model numbers | FP3L4 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0493-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.