Siemens Healthcare Diagnostics, Inc.: Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;

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.

Details from the source

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. Distribution: Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland. Quantity: 5,371 units (4,394 US, 977 OUS) Lot/code info: Siemens Material Number (SMN): 10445146; UDI-DI: 00842768015717; Lot Number: 23206BA;

UPC codes

00842768015717

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.