Siemens Healthcare recalls ADVIA Centaur DHEA-SO4 kits due to incorrect biotin interference levels in instructions. Users may need to check kit lot numbers for affected products.
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 DHEA-SO4 kits because the instructions incorrectly list biotin interference levels. This could lead to inaccurate test results if users follow the outdated instructions.
The instructions for use list incorrect biotin interference levels. This means tests might show false results if users follow the outdated instructions without updating to the corrected information.
Users of ADVIA Centaur DHEA-SO4 kits for hormone testing are affected. Those who follow the outdated instructions may get inaccurate test results.
Check the lot numbers on the kit: 00119053, 14041053, 80449053, 90520053, 29750054, 30423054, 39155054, 50533054, 63267055, 68936055, 79273055, 86427055, 06402057, 07109057, 14187057, 37499057.
Look for the specific lot numbers listed in the recall notice to identify affected kits.
The instructions for use incorrectly list the biotin interference levels, which could lead to inaccurate test results if users follow the outdated information.
Check the lot numbers on the kit to see if it's affected. If it is, you may need to follow the corrected instructions for accurate test results.
No, this recall is about potential inaccurate test results, not physical harm.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1688-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1688-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.