Siemens Healthcare recalls Dimension Vista TSH Flex reagent cartridges with incorrect biotin concentration levels in instructions, potentially affecting lab test accuracy. Affected lots include 16277BD to 17268AA.
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 Dimension Vista TSH Flex reagent cartridges because the instructions incorrectly list biotin levels that could interfere with lab tests. This might lead to inaccurate thyroid hormone test results if the cartridges are used without correction.
The instructions for use incorrectly state the biotin concentration levels that do not interfere with the test. This could cause false test results if the cartridges are used without adjusting for the error.
Lab technicians and healthcare providers who use the Dimension Vista TSH Flex reagent cartridges for thyroid hormone testing. Those using the affected lots are most at risk of inaccurate test results.
Check the lot code on the cartridge, which is listed as 16277BD, 16322BB, 17005BB, 17023AC, 17069AA, 17093BB, 17122AA, 17150AA, 17193BA, 17215AC, or 17268AA.
Look for the lot code on the cartridge, which is one of the listed codes: 16277BD, 16322BB, 17005BB, 17023AC, 17069AA, 17093BB, 17122AA, 17150AA, 17193BA, 17215AC, or 17268AA.
The instructions for use incorrectly list the biotin concentration levels that do not interfere with the test, which could lead to inaccurate thyroid hormone test results.
Affected lots include 16277BD, 16322BB, 17005BB, 17023AC, 17069AA, 17093BB, 17122AA, 17150AA, 17193BA, 17215AC, and 17268AA.
No, the recall does not require stopping use. The issue is with the instructions, not the cartridges themselves, so they can be used with adjustments to the test process.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1673-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1673-2018 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.
