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Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Recalled September 18, 2024 · FDA recall Z-3065-2024 · Siemens Healthcare Diagnostics
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. · FDA Class II
Units
5,371 units (4,394 US, 977 OUS)
Sold at
Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland.
Description
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.
Product
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →