FDA recall Z-1648-2022

Siemens Healthcare Diagnostics, Inc. · Class II · device

Product

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

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2022-07-18
Report date: 2022-09-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Newark, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1648-2022