FDA Device recall Z-1821-2025
Atellica IM Homocysteine Calibrator (2 Pack)
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of Atellica IM Homocysteine Calibrator (2 Pack) by Siemens Healthcare Diagnostics, citing 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 instabil….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1821-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-15 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Reason
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.
Identifiers
| code_info | Siemens Material Number: 10995498. UDI-DI: 00630414598253 Kit lot numbers: 86236A74, 44206A75. ***Updated 5/8/26**…Siemens Material Number: 10995498. UDI-DI: 00630414598253 Kit lot numbers: 86236A74, 44206A75. ***Updated 5/8/26*** Additional Lots 25675A77, 44505A78, 52364A79. |
|---|
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-1821-2025%22
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