Siemens Healthcare recalls IMMULITE 2000 Gastrin tests due to potential biotin interference. Affected lots 251-255 may give 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 specific IMMULITE 2000 Gastrin tests because they can give inaccurate results when biotin is present in samples. This could lead to incorrect test results if the test is used without proper biotin management.
The test kits can be affected by biotin in samples, which may cause inaccurate gastrin measurements. This interference occurs because the test instructions don't list the biotin concentration that doesn't interfere, leading to potential false results.
Lab users who test with the recalled IMMULITE 2000 Gastrin kits (lot numbers 251-255) may experience inaccurate results if biotin is present in their samples. Patients using these tests for gastrin monitoring are at risk of incorrect results.
Check the lot number on the IMMULITE 2000 Gastrin test kit. Affected lots are 251, 252, 253, 254, and 255. These kits were sold with the specific product names listed in the recall.
Look for the lot number on the IMMULITE 2000 Gastrin test kit. Affected lots are 251 through 255.
The test kits can give inaccurate results if biotin is present in samples because the instructions don't list the biotin concentration that doesn't interfere.
Check the lot number on the test kit. If it's 251-255, contact Siemens Healthcare for guidance on next steps.
No, the recall is for potential inaccurate test results, not physical harm.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1681-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1681-2018 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.
