Atellica IM Homocysteine Calibrator — Class II medical device recall Z-1821-2025
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2025-06-04, distributed nationwide. Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Ins
| Recall number | Z-1821-2025 |
|---|---|
| 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 | 2025-04-15 |
| Classified | 2025-05-27 |
| Reported by FDA | 2025-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, CH, CW, CZ, DE, DK, EG, ES, FI, FR, GR, HR, HU, IE, IL, IR, IT, JO, KW, LT, LV, NL, NO, NP, PK, PL, PT, RO, RS, SE, SK, TR |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414598253 |
| Lot numbers | 25675A77, 44206A75, 44505A78, 52364A79, 86236A74 |
Product
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Reason for recall
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
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-1821-2025. 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.