Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1924-2013)

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 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.

Product Classification:

Class II

Date Initiated: July 1, 2013

Date Posted: August 14, 2013

Recall Number: Z-1924-2013

Event ID: 65706

Reason for Recall:

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.

Status: Terminated

Product Quantity: 5423

Code Information:

TACR Flex Reagent cartridge, material #10444938, (DF107) lot BB4087 with expiration date 3/28/14 and its linked calibrator, material #10445012, (DC 107) lot 3BD029 with expiration date 03/01/14.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated