Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-3065-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;

Product Classification:

Class II

Date Initiated: July 30, 2024

Date Posted: September 18, 2024

Recall Number: Z-3065-2024

Event ID: 95116

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.

Status: Ongoing

Product Quantity: 5,371 units (4,394 US, 977 OUS)

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.

Voluntary or Mandated:

Voluntary: Firm initiated