Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0957-2013)

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:

Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.

Product Classification:

Class II

Date Initiated: November 27, 2012

Date Posted: March 27, 2013

Recall Number: Z-0957-2013

Event ID: 63767

Reason for Recall:

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

Status: Terminated

Product Quantity: 2,976

Code Information:

Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated