Siemens Dimension Tacrolimus Flex Reagent Cartridge — Class II medical device recall Z-2398-2026
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2026-06-17, distributed nationwide. A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Ta
| Recall number | Z-2398-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2026-05-07 |
| Classified | 2026-06-10 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BR, DE, ES, HR, HU, IN, IT, JP, KR, LK, LT, PK, PL, SA, TR, ZA |
| Quantity | 2,878 units |
| UPC / GTIN / UDI-DI | 00842768035425 |
| Serial numbers | FA6254, FA6260, FA6286 |
| Model numbers | 10700795, DF207 |
Product
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Reason for recall
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
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-2398-2026. 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.