Z-1924-2013Class II

Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107)

Name: Z-1924-2013 Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-07-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-07-01 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to... on 2013-07-01. FDA classified it as Class II and gives the reason as "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...". 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-1924-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-01
Posted: 2013-08-07
Terminated: 2014-08-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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 code: MLM Enzyme Immunoassay, Tracrolimus
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens sent an Urgent Medical Device Recall letter dated July 2013 to affected customers The letter identified the affected product, problem, potential risk, and actions to be taken by customers. Customers were requested to discuss the letter with thier laboratory director to determine if additional follow up is appropriate for patient tests conducted with the affected device lots. Additionally, customers were asked to discard any remaining inventory and to complete and return the field correction effectiveness check for replacement product. They were also asked to forward the letter to anyone wha had received this affected product. For questions contact your Siemens Technical Solutions Center or your local Siemens Technical support representative.
Quantity in commerce: 5423
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1924-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1924-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-07

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)