FDA-Device2026-06-17Class IIPROCESSING DEFECT
Siemens Dimension Tacrolimus Flex Reagent Cartridge recalled for positive bias in test results
OTHERNationwide distribution
Siemens Dimension Tacrolimus Flex Reagent Cartridge recalled for result bias
Three lots of Siemens Dimension Tacrolimus Flex Reagent Cartridges show a potential positive bias in quality control and patient test results. This means the cartridges may report tacrolimus levels that are higher than actual values. The affected lots are FA6254, FA6260, and FA6286.
- If you operate a laboratory using this device, check whether you have cartridges from lots FA6254, FA6260, or FA6286
- Contact Siemens Healthcare Diagnostics for guidance on how to handle or return affected cartridges
- Review recent test results from these lots, especially for patients on tacrolimus therapy, in consultation with your clinical team
Hazard
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Sold states
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.
Affected count
2878 units
Manufactured in
500 Gbc Dr, N/A, Newark, DE, United States
Products
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2398-2026More Siemens Healthcare Diagnostics, Inc. recalls
- FDA-Device2026-04-08Siemens Atellica CH A1c_E test kit recalled for potentially low results
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