Medical Device Recall: Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Siemens Healthcare Diagnostics, Inc. · May 7, 2026
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.
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.
States Affected
NATIONWIDE
Quantity Affected
2878 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2398-2026
Status: ongoing
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