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Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic tes
Recalled March 27, 2013 · FDA recall Z-0957-2013 · Siemens Healthcare Diagnostics
Hazard
Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values · FDA Class II
Units
2,976
Sold at
Product was distributed within the United States to AL, AZ, CA, DC, FL, LA, MD, MI, MO, NJ, NM, NC, OH, OR, PA, TN, TX, UT, VA, and WA.
Description
Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values
Product
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →