Siemens Healthcare recalls Dimension Sirol: Biotin interference may affect allergy, cancer, and vitamin tests. Affected lots: BB7336, FA8037, FA8081, BB8167, FB8177, FB8219. Stop using if tests show inaccurate results.
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Siemens Healthcare is recalling Dimension Sirolimus reagent cartridges that may cause inaccurate test results due to biotin interference. This affects allergy, cancer, and vitamin tests. Users should check their lot numbers and contact Siemens if they have the affected cartridges.
The reagent cartridges may not properly account for biotin levels in blood samples, leading to inaccurate test results for certain assays. This could affect allergy, cancer biomarker, and vitamin tests.
Users of Dimension Sirolimus reagent cartridges for blood tests, particularly those running specific allergy, cancer, and vitamin tests. People with the affected lot numbers are most at risk.
Check the lot number on the cartridge: BB7336, FA8037, FA8081, BB8167, FB8177, or FB8219. The product is sold under the brand name Dimension Sirolimus (SIRO) Flex reagent cartridge.
Look for lot numbers BB7336, FA8037, FA8081, BB8167, FB8177, or FB8219 on the cartridge.
Allergy, cancer biomarker, and vitamin tests such as CEA, Gastrin, Folic Acid, and Vitamin B12.
Check the lot number on the cartridge: BB7336, FA8037, FA8081, BB8167, FB8177, or FB8219.
No, but if tests show inaccurate results, contact Siemens Healthcare for guidance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1670-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1670-2018 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.
