IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS — Class II medical device recall Z-0717-2023

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-0717-2023`
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	5,193 kits
Reason classes	undeclared allergen, microbial contamination
Pathogens	mold
UPC / GTIN / UDI-DI	`00630414962269`
Lot numbers	`826`, `830`, `831`, `832`, `833`

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.

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-0717-2023. 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.