Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result |
| Product | 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. |
| Quantity | 5,193 kits |
| Distribution | Worldwide distribution. US Nationwide, Argentina® Australia® Austria® Azerbaijan® Belgium® Brazil® Chile® Colombia® CostaRica® Croatia® CzechRepublic® Denmark® Ecuador® Egypt® Estonia® France® Germany® Guatemala® HongKong® Hungary® Indonesia® Israel® Italy® … |
| Initiated | 2022-11-04 |
| Classified | 2022-12-15 |
| Recall number | Z-0717-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-0717-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91164/
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