Siemens Dimension Tacrolimus Flex Reagent Cartridge
Siemens is recalling Dimension Tacrolimus Flex reagent cartridges due to a potential positive bias in test results.
Healthcare providers should discontinue use of the affected lots and contact Siemens Healthcare Diagnostics for further instructions regarding replacement or return.
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?
This recall covers the product below. If you have it, yours is affected.
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Official source
Other recent recalls from Siemens Healthcare Diagnostics, Inc.
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification