Siemens Healthcare recalls IMMULITE 2000/2000 XPi CEA tests due to potential biotin interference. Affected lots may give inaccurate results if biotin levels are high.
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 certain IMMULITE 2000 and 2000 XPi CEA blood tests because they can give inaccurate results if biotin levels in your blood are high. This could lead to incorrect health assessments.
The tests can give inaccurate results if biotin levels in your blood are high. Biotin is a vitamin found in some supplements and foods. The recall is for specific lots of these tests that don't list the biotin interference levels in their instructions.
People who use these specific IMMULITE 2000/2000 XPi CEA tests for blood work, particularly those with high biotin levels in their blood. Those with biotin supplements or certain medical conditions may be at higher risk.
Check the lot code on the test packaging. Affected lots have codes 0355, 0356, or 0357. These tests are labeled as IMMULITE 2000 or IMMULITE 2000 XPi with CEA.
Look for lot codes 0355, 0356, or 0357 on the test packaging.
The tests can give inaccurate results if biotin levels in your blood are high, as the instructions don't list the biotin interference levels.
No, but you should check the lot code to see if you have an affected test. If you do, you may want to contact your healthcare provider for alternative testing.
Check the lot code on the test packaging. If it's 0355, 0356, or 0357, contact your healthcare provider for alternative testing options.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1679-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1679-2018 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.
