FDA Device recall Z-3065-2024
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge by Siemens Healthcare Diagnostics, citing 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 fillin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3065-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-30 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Reason
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.
Identifiers
| code_info | Siemens Material Number (SMN): 10445146; UDI-DI: 00842768015717; Lot Number: 23206BA; |
|---|
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-3065-2024%22
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