FDA-Device2024-09-18Class II
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Siemens Healthcare Diagnostics, Inc.
Hazard
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.
Sold states
Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland.
Affected count
5,371 units (4,394 US, 977 OUS)
Manufactured in
500 Gbc Dr, Newark, DE, United States
Products
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3065-2024Don't want to check this manually?
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