Siemens Healthcare recalls Dimension Vista CTNI Flex reagent cartridges due to potential biotin interference in specific lab tests. Affected lots may cause inaccurate results if biotin is present in samples.
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 CTNI Flex reagent cartridges that could give inaccurate lab results if biotin is present in patient samples. This affects specific tests for cardiac troponin I and other biomarkers.
The reagent cartridges lack instructions for biotin concentrations that could cause interference. Biotin is a common supplement and can affect certain lab tests, leading to inaccurate results for cardiac troponin I and other biomarkers.
Lab users who run the Dimension Vista CTNI Flex reagent cartridges with lot codes listed above are affected. Patients undergoing tests using these cartridges may see inaccurate results if biotin is present in their samples.
Check the lot code on the cartridge, which is listed as 16336BA through 17264BC. The product is used in Siemens Dimension Vista lab systems for cardiac troponin I testing.
Look for the lot code on the cartridge, which is one of the listed codes (16336BA to 17264BC).
The reagent cartridges do not list biotin concentrations that could interfere with certain lab tests, potentially causing inaccurate results for cardiac troponin I and other biomarkers.
Tests including cardiac troponin I (CTNI), Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM, and specific IMMULITE assays like 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12.
The recall does not require stopping use; lab users should check the lot code and verify if the cartridge is affected before continuing testing.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1671-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1671-2018 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.
