Siemens Healthcare recalls specific allergy test kits that may show false mold allergies, affecting patients with certain test lots. No action needed for most users.
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
Siemens Healthcare is recalling specific allergy test kits that can give false positive results for mold. This means patients might be incorrectly diagnosed with mold allergies when they don't have them.
The test kits may react falsely with mold allergens in the quality control materials and patient samples. This can lead to incorrect diagnoses of mold allergies when none exist.
Patients using the recalled IMMULITE 2000 allergy test kits with specific lot numbers (826, 830, 831, 832, 833) may get false positive mold allergy results. Healthcare providers ordering these kits are most at risk.
Check the kit lot number on the packaging. The recalled lots are 826, 830, 831, 832, or 833. These kits were sold in the U.S. except Japan.
Look for the lot number on the test kit packaging; if it is 826, 830, 831, 832, or 833, it is part of the recall.
No action is needed for most users. The recall only affects specific test lots that may give false positive mold results.
Check the lot number on the packaging. If it is 826, 830, 831, 832, or 833, contact Siemens Healthcare for instructions.
Yes, the test kits are safe to use if they are not part of the recalled lots. The hazard only affects specific lots that may give false positive results.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0717-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0717-2023 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.
