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.
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
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.
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.
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.
Check the manufacturing lot numbers: FA6254, FA6260, or FA6286. The cartridges are part of Siemens Dimension Tacrolimus Flex reagent system for enzyme immunoassays.
Look for lot numbers FA6254, FA6260, or FA6286 on the cartridge packaging.
The recall is due to a potential positive bias in quality control and patient sample results for specific lots of the Dimension Tacrolimus Flex reagent cartridge.
Using the recalled cartridge could lead to inaccurate test results, potentially causing incorrect medical decisions.
Check the lot numbers: FA6254, FA6260, or FA6286. These are the specific lots affected by the recall.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2398-2026 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2398-2026 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
