Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1648-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456

Product Classification:

Class II

Date Initiated: July 18, 2022

Date Posted: September 7, 2022

Recall Number: Z-1648-2022

Event ID: 90669

Reason for Recall:

Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.

Status: Ongoing

Product Quantity: 129 units US; 159 units OUS

Code Information:

UDI: 0084276802852621340BB22120610464344840, 0084276802852622049BC23021810464344840, 0084276802852622112BF23042210464344840. Lot Numbers: lot 21340BB Exp Date: 2022-12-06; lot 22049BC (corrected lot number 9/8/2022) Exp Date: 2023-02-18; lot 22112BF Exp Date: 2023-04-20.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated