Z-2398-2026Class II

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay

Name: Z-2398-2026 Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2026-05-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-05-07 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay on 2026-05-07. FDA classified it as Class II and gives the reason as "A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2398-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-07
Posted: 2026-06-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Product code: MLM Enzyme Immunoassay, Tracrolimus
Reason for recall: A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
FDA root cause: Under Investigation by firm
Action: Siemens Healthineers issued an Urgent Medical Device Correction notice to its consignees on 5/12/2026 via FedEx. The notice described the issue, its impact to QC and patient results, and requested the following: "Customer Actions . Immediately discontinue use of and discard the affected kit lot numbers. . Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. . Review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for required regulatory reporting. . Complete and return the Field Correction Effectiveness Check Form attached to this letter within (30) days. . Please retain this letter with your laboratory records and forward it to anyone who may have received or used this product." For questions, contact your Siemens Healthineers Customer Care Center at (312) 275-7795 or your local Siemens Healthineers technical support representative.
Quantity in commerce: 2878 units
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Brazil, Croatia, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Pakistan, Poland, Saudi Arabia, Spain, South Africa, Sri Lanka, Turkey, United Arab Emirates.
Product codes and lots: Manufacturing Lot/Serial Numbers: FA6254, FA6260, FA6286; UDIs: (01)00842768035425(10)FA6254(17)20260911; (01)00842768035425(10)FA6260(17)20260917; (01)00842768035425(10)FA6286(17)20261013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2398-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2398-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-10

Product code MLM

K150168Class IIDimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)Siemens Healthcare Diagnostics / cleared 2015-11-04

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)