Z-0957-2013Class II

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

Name: Z-0957-2013 Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-11-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-11-27 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test on 2012-11-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0957-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-27
Posted: 2013-03-15
Terminated: 2014-08-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Product code: MLM Enzyme Immunoassay, Tracrolimus
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated their recall of this product on November 27, 2012 by sending a letter to all consignees. The letter included a recall effectiveness check form to be completed by the consignee and returned to the firm. The firm expanded their recall on January 29, 2013 by sending another letter to consignees. This letter also included a recall effectiveness check form to be completed by the consignee and returned to the firm.
Quantity in commerce: 2,976
Distribution: 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.
Product codes and lots: Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0957-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0957-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-15

Product code MLM

K060502Class IIDimension Tacr Flex Reagent Cartridge, Model Df107Dade Behring, Inc. / cleared 2006-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)