Siemens Healthcare recalls IMMULITE 2000 allergy test kits that may show false mold allergies. These kits use a specific IgE test for allergies in Japan. Affected kits have Siemens Material Number 10711939.
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 test kits may react falsely with mold allergens, causing the system to show a positive result when there is no actual allergy. This could lead to incorrect diagnoses and unnecessary treatments.
Allergy test users in Japan who have the specific IMMULITE 2000 allergy kits with Siemens Material Number 10711939 are affected. People with mold allergies may be at higher risk of misdiagnosis.
Check for the Siemens Material Number 10711939 on the kit. These kits were sold in Japan for allergy testing and are part of the IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests.
Look for the Siemens Material Number 10711939 on the kit label to confirm if it's affected.
The recall states a potential for false positive results, not direct health risks. The tests may lead to incorrect diagnoses but do not cause immediate harm.
Check for the Siemens Material Number 10711939 on the kit label. These kits were sold in Japan for allergy testing.
The recall does not specify a remedy, so no action is required. Check the kit details to confirm if it's affected.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0718-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0718-2023 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.
