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Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Recalled June 17, 2026 · FDA recall Z-2398-2026 · Siemens Healthcare Diagnostics
Hazard
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. · FDA Class II
Units
2878 units
Sold at
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.
Description
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Product
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →