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

FDA device recall Z-2398-2026 · posted 2026-06-10 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MLM

Quantity affected

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 A

Date initiated

2026-05-07

Date posted

2026-06-10

Location

Newark, DE

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