Siemens IMMULITE 2000 Allergy Tests May Give False Positive Mold Results
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.
Lower-risk recall
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/59494-siemens-immulite-2000-allergy-tests-may-give-false-positive-mold.
Source Summary by GovInfoNow · govinfonow.com/recall/59494-siemens-immulite-2000-allergy-tests-may-give-false-positive-mold · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0718-2023
Cite this page
“Siemens IMMULITE 2000 Allergy Tests May Give False Positive Mold Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59494-siemens-immulite-2000-allergy-tests-may-give-false-positive-mold. Based on FDA recall #Z-0718-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0718-2023%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Siemens Healthcare- Product
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution. US Nationwide, Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Azerbaijan¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Brazil¿¿¿¿¿¿¿¿¿ Chile¿¿¿¿¿¿¿¿¿¿ Colombia¿¿¿¿¿¿¿ Costa¿Rica¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Ecuador¿¿¿¿¿¿¿¿ Egypt¿¿¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Guatemala¿¿¿¿¿¿ Hong¿Kong¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Indonesia¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿ Japan¿¿¿¿¿¿¿¿ Latvia¿¿¿¿¿¿¿¿¿ Lithuania¿¿¿¿¿¿ Macedonia¿¿¿¿¿¿ Mexico¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Panama¿¿¿¿¿¿¿¿¿ Paraguay¿¿¿¿¿¿¿ Philippines¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Russian¿Fed.¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ South¿Africa¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ Ukraine¿¿¿¿¿¿¿¿ United¿Kingdom¿ Uruguay, and Uzbekistan¿¿¿¿¿
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0716-2023 | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.; UDI-DI (01)00630414982939(10)D830(17)20221130; (01)00630414982939(10)D831(17)20221130; (01)00630414982939(10)D832(17)20221130; (01)00630414982939(10)D833(17)20221130. Lot Numbers: D830, D831, D832, D833 | 1000 kits |
| Z-0717-2023 | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.; UDI:-DI: (01)00630414962269(10)826(17)20221130; (01)00630414962269(10)830(17)20221130; (01)00630414962269(10)831(17)20221130; (01)00630414962269(10)832(17)20221130; (01)00630414962269(10)833(17)20221130. Kit Lots: 826, 830, 831,832, 833 | 5,193 kits |
| Z-0718-2023 | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.; UDI:-DI: (01)00630414278735(10)565(17)20221130 Kit Lot 565 | 560 kits |
What to do — step by step
Check Kit Details
Look for the Siemens Material Number 10711939 on the kit label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution. US Nationwide, Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Azerbaijan¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Brazil¿¿¿¿¿¿¿¿¿ Chile¿¿¿¿¿¿¿¿¿¿ Colombia¿¿¿¿¿¿¿ Costa¿Rica¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0718-2023 (November 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0718-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.