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Siemens Healthcare Diagnostics, Inc. recalls Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is
Recalled August 14, 2013 · FDA recall Z-1924-2013 · Siemens Healthcare Diagnostics
Hazard
Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing. · FDA Class II
Units
5423
Sold at
USA Nationwide Distribution including the states of: TX, NC, GA, TN, UT, NJ, MI, VA, AR, LA, MO, FL, AZ, CA, DC, PA, NH, WI, SD, SC, NM, MD, and IN.
Description
Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing.
Product
Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →