Siemens Healthcare Diagnostics, Inc.: Enzyme Immunoassay, Tracrolimus
Siemens is recalling specific lots of a reagent cartridge used to measure tacrolimus (a drug used after organ transplants) in patient blood samples because the cartridge may produce falsely high results. The affected cartridge is the Dimension Tacrolimus Flex with reference number DF207, and it was distributed worldwide including throughout the United States and multiple other countries. This is a Class II recall, meaning the product could cause serious health consequences but is not expected to cause death.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
- Reason
- A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-07
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e33aea2f-9d0b-430b-9f0c-5ca62b49eefa