Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0517-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 25, 2013

Date Posted: December 25, 2013

Recall Number: Z-0517-2014

Event ID: 65051

Reason for Recall:

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

Status: Terminated

Product Quantity: 13,751

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.

Voluntary or Mandated:

Voluntary: Firm initiated