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Siemens Dimension Tacrolimus Flex Reagent Cartridge
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MEDICAL DEVICE RECALLMODERATE

Siemens Dimension Tacrolimus Flex Reagent Cartridge

Siemens is recalling Dimension Tacrolimus Flex reagent cartridges due to a potential positive bias in test results.

What to do

Healthcare providers should discontinue use of the affected lots and contact Siemens Healthcare Diagnostics for further instructions regarding replacement or return.

Recalled
Listed
Updated
Recall No.
Z-2398-2026
Agency
FDA
Firm
Siemens Healthcare Diagnostics, Inc.
Recall ID
98985
Status
ONGOING

Recall at a glance

Quantity recalled
2878 units

Why it was recalled

Siemens Healthcare Diagnostics is recalling specific lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge due to a potential positive bias in quality control and patient sample results. This issue may lead to inaccurate test results.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UDI-DI
00842768035425, 20260911, 00842768035425, 20260917, 00842768035425, 20261013

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

Other recent recalls from Siemens Healthcare Diagnostics, Inc.

All recalls from Siemens Healthcare Diagnostics, Inc.

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification