Siemens Healthcare recalls Dimension Vista MMB reagent cartridges due to potential biotin interference in certain lab tests. Affected lots may cause inaccurate results if biotin levels are not properly controlled.
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 Vista MMB reagent cartridges because they can cause inaccurate lab test results if biot:in levels are not properly controlled. This affects specific test kits that use biotin in their process.
The reagent cartridges lack clear instructions for biotin concentrations that prevent interference. This can lead to inaccurate lab results for certain tests, including those measuring specific proteins and vitamins.
Lab technicians and healthcare providers who use Siemens Dimension Vista MMB reagent cartridges for specific tests. Those handling the affected lots are most at risk of inaccurate test results.
Check for lot codes: 16284BD, 16312BB, 17011BD, 17058BD, 17093BC, 17136BE, 17186BE, 17235BC, 17268BA. The product is a Dimension Vista MMB Flex reagent cartridge with model number K6420.
Verify the lot code on the cartridge to see if it matches the affected lots listed: 16284BD, 16312BB, 17011BD, 17058BD, 17093BC, 17136BE, 17186BE, 17235BC, 17268BA.
Tests that measure biotin-sensitive markers, including specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12.
The reagent cartridges do not have clear instructions for biotin concentrations that prevent interference, which can lead to inaccurate lab results for certain tests.
Check the lot code on the cartridge; affected lots are 16284BD, 16312BB, 17011BD, 17058BD, 17093BC, 17136BE, 17186BE, 17235BC, 17268BA.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1672-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1672-2018 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.
