Device product
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Z-3065-2024
Product summary
- Event
- Event 95116
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,371 units (4,394 US, 977 OUS)
- Official record key
device-enforcement:Z-3065-2024
Official wording
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.
Code information: Siemens Material Number (SMN): 10445146; UDI-DI: 00842768015717; Lot Number: 23206BA;
Distribution pattern: Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland.
Derived failure modes
-
Unknown
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.