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Recall Observatory FDA recall evidence

Device product

Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients

Z-0517-2014

April 25, 2013

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 65051
Status
Terminated
Classification
Class II
Quantity
13,751
Official record key
device-enforcement:Z-0517-2014

Official wording

Reason: Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.

Code information: Siemens Material Number 10444938, lot numbers GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267 and FB3267.

Distribution pattern: Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.