Siemens Healthcare recalls IMMULITE 1000 CEA devices due to unlisted biotin concentrations causing false results in certain tests. Affected units have specific lot codes.
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 IMMULITE 1000 CEA blood test devices because they may give false results if biotin levels are not properly listed in the instructions. This could lead to inaccurate health assessments.
The devices may produce false test results if biotin levels in the patient's blood are not accounted for in the instructions. This happens because the current instructions don't list the specific biotin concentrations that could interfere with certain tests.
Individuals using the IMMULITE 1000 CEA blood test devices with lot codes 0355, 0356, or 0357 are affected. Patients relying on these tests for health monitoring are most at risk.
Check the lot code on the device, which should be 0355, 0356, or 0357. The affected models are IMMULITE 1000 CEA devices used for specific blood tests.
Look for the lot code on the device, which should be 0355, 0356, or 0357.
The IMMULITE 1000 CEA devices may affect tests for CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12.
Check the lot code on the device; affected units have lot codes 0355, 0356, or 0357.
The recall does not require stopping use immediately; affected devices should be checked for the lot code.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1678-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1678-2018 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.
