Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall: Potential QC Errors in Patient
Siemens recalls Dimension Tacrolimus Flex reagent cartridges (lots FA6254, FA6260, FA6286) due to possible positive bias in quality control and patient test results. Affected units may show inaccurate results.
Lower-risk recall
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Contact the company
What happened, in plain English
Siemens is recalling specific lots of their Dimension Tacrolimus Flex reagent cartridges because they could cause positive bias in quality control and patient test results. This means some test results might be inaccurate, potentially leading to incorrect medical decisions. Read more at govinfonow.com/recall/49203-siemens-dimension-tacrolimus-flex-reagent-cartridge-recall-potential-qc-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/49203-siemens-dimension-tacrolimus-flex-reagent-cartridge-recall-potential-qc-errors · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2398-2026
Cite this page
“Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall: Potential QC Errors in Patient.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49203-siemens-dimension-tacrolimus-flex-reagent-cartridge-recall-potential-qc-errors. Based on FDA recall #Z-2398-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2398-2026%22&limit=1).
Why it’s dangerous
The reagent cartridges could produce false positive results in quality control and patient samples. This might lead to incorrect medical decisions if the test results are used for diagnosis or treatment.
Who’s affected
Healthcare facilities using the recalled reagent cartridges for enzyme immunoassays are affected. Patients receiving tests with these cartridges may be at risk of inaccurate results.
How to tell if you have this one
Check the manufacturing lot numbers: FA6254, FA6260, or FA6286. The cartridges are part of Siemens Dimension Tacrolimus Flex reagent system for enzyme immunoassays.
- Brand
Siemens Healthcare- Product
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay- Category
Medical device
What to do — step by step
Check Cartridge Lot Numbers
Look for lot numbers FA6254, FA6260, or FA6286 on the cartridge packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2398-2026 (May 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2398-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.