Siemens Healthcare recalls ADVIA Centaur Cyclosporine due to incorrect biotin interference levels in instructions. This may lead to inaccurate test results for cyclosporine levels. Affected units have specific lot numbers listed in the recall notice.
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere
Siemens Healthcare is recalling ADVIA Centaur Cyclosporine test kits because the instructions incorrectly list biotin interference levels. This could cause inaccurate cyclosporine test results, potentially affecting patient treatment decisions.
The instructions for use incorrectly state the biotin levels that do not interfere with cyclosporine testing. This could lead to inaccurate test results, which might affect treatment decisions for patients on cyclosporine.
Patients using cyclosporine tests with the ADVIA Centaur Cyclosporine kit are affected. Those with specific lot numbers listed in the recall notice are most at risk.
Check the lot numbers on the kit: 38182025, 64432025, 98554025, 58299030, 25547030, 30153031, 77934031, 97170031. The product is labeled as ADVIA Centaur Cyclosporine.
Verify the lot number on your kit matches any of the listed numbers: 38182025, 64432025, 98554025, 58299030, 25547030, 30153031, 77934031, 97170031.
The instructions for use incorrectly state the biotin levels that do not interfere with cyclosporine testing, which could lead to inaccurate test results.
Check the lot number on your kit against the listed numbers. If it matches, contact Siemens Healthcare for further instructions.
No, the hazard is related to inaccurate test results, not physical harm. The danger level is low risk.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1687-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1687-2018 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.
