Dimension Vista¿ Total Bilirubin — Class II medical device recall Z-3065-2024
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-09-18, distributed nationwide. During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processe
| Recall number | Z-3065-2024 |
|---|---|
| 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 | 2024-07-30 |
| Classified | 2024-09-06 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CZ, DE, DK, ES, FR, IT, QA, SI |
| UPC / GTIN / UDI-DI | 00842768015717 |
| Lot numbers | 23206BA |
Product
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Reason for recall
During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.
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-3065-2024. 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.