Siemens Healthcare recalls specific allergy test kits that may produce false positive mold results. Affected kits have Siemens Material Number 10708840 and lot numbers D830-D833. Users should contact Siemens for details.
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 allergy test kits that might show false positive results for mold. This could lead to incorrect allergy diagnoses and unnecessary treatments. The affected kits have specific lot numbers and material codes.
The test kits may react falsely with mold allergens, causing false positive results. This could lead to incorrect allergy diagnoses and unnecessary treatments. The issue is specific to certain batches of the test kits.
Allergy test users who have the specific kits with Siemens Material Number 10708840 and lot numbers D830-D833 are affected. People with mold allergies may be at higher risk of misdiagnosis.
Check for Siemens Material Number 10708840 and lot numbers D830, D831, D832, or D8833 on the test kits. The kits are labeled for use with Siemens IMMULITE 2000 Systems Analyzers.
Look for Siemens Material Number 10708840 and lot numbers D830-D833 on the test kits.
The test kits may show false positive results for mold allergens, leading to incorrect allergy diagnoses.
Check for Siemens Material Number 10708840 and lot numbers D830, D831, D832, or D833 on the test kits.
Contact Siemens Healthcare for details on next steps; the recall does not include a specific remedy.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0716-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0716-2023 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.
