IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests — Class II medical device recall Z-0716-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-12-21, distributed nationwide. Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient
| Recall number | Z-0716-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., East Walpole, MA, United States |
| Recall initiated | 2022-11-04 |
| Classified | 2022-12-15 |
| Reported by FDA | 2022-12-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CH, CL, CO, CZ, DE, DK, EC, EE, EG, ES, FR, GT, HR, HU, ID, IL, IT, JP, LT, LV, MX, NL, NO, PA, PH, PK, PL, PT, PY, RO, RS, SE, SI, SK, TR, TW, UA, UY |
| Quantity | 1,000 kits |
| Reason classes | undeclared allergen, microbial contamination |
| Pathogens | mold |
| UPC / GTIN / UDI-DI | 00630414982939 |
| Lot numbers | D830, D831, D832, D833 |
Product
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.
Reason for recall
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0716-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.