Siemens Healthcare recalls IMMULITE 2000/2000 XPi 3g Allergy kits with specific lot numbers due to potential biotin interference in certain tests. Affected kits 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 lots of IMMULITE 2000/2000 XPi 3g Allergy specific IgE Universal Kits because they may interfere with certain tests when biotin is present in samples. This could lead to inaccurate test results for conditions like allergies and other health markers.
The recalled kits may produce inaccurate test results when biotin is present in the sample. Biotin is a common vitamin found in some foods, supplements, and medications. This interference can lead to false positive or negative results for specific health tests.
People using the recalled IMMULITE 2000/2000 XPi 3g Allergy specific IgE Universal Kits with lot numbers 461-476 and D463-D476 are affected. Those who test for allergies or other health conditions using these kits may get inaccurate results.
Check the lot number on the kit packaging. The affected lots are numbered 461-476 and D463-D476. The kits are labeled as '3g Allergy specific IgE Universal Kit' for Siemens IMMULITE 2000/2000 XPi systems.
Look for the lot number on the kit packaging, which should be between 461-476 or D463-D476.
The recalled kits may interfere with certain tests when biotin is present in samples, leading to inaccurate results for allergies and other health markers.
Check the lot number on the kit packaging. If it's in the affected range (461-476 or D463-D476), contact Siemens Healthcare for instructions.
The kit may still be used safely if you avoid biotin-containing samples, but the recall is for potential inaccurate results, not immediate danger.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1674-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1674-2018 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.
