Siemens Healthcare recalls IMMULITE Gastrin test kits with lot numbers 0345-0347 due to potential biotin interference in results. Users should check their test kit lot numbers and contact Siemens for guidance.
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 Gastrin test kits with specific lot numbers because they may give inaccurate results if biotin is present in the sample. This could lead to incorrect health assessments.
The test kits may produce incorrect results if biotin is present in the sample. Biotin is a common vitamin found in some foods and supplements. This interference could lead to wrong health conclusions.
People who use IMMULITE Gastrin test kits with lot numbers 0345, 0346, or 0347 are affected. Those with high biotin levels in their blood may experience inaccurate test results.
Check the lot number on the IMMULITE Gastrin test kit. Affected kits have lot numbers 0345, 0346, or 0347. The product is sold under the brand name IMMULITE.
Look for the lot number on the IMMULITE Gastrin test kit. Affected kits have lot numbers 0345, 0346, or 0347.
The IMMULITE Gastrin test kits with lot numbers 0345, 0346, and 0347 may give inaccurate results if biotin is present in the sample.
Check the lot number on your IMMULITE Gastrin test kit. If it is 0345, 0346, or 0347, contact Siemens Healthcare for guidance.
This is a low-risk issue as it may cause inaccurate test results but does not pose a direct safety risk.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1680-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1680-2018 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.
