FDA-Device2013-03-27Class II
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Siemens Healthcare Diagnostics, Inc.
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
Sold states
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.
Affected count
2,976
Manufactured in
500 GBC Drive, Mailstop 514, PO BOX 6101, Newark, DE, United States
Products
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0957-2013Don't want to check this manually?
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