IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy — Class II medical device recall Z-1843-2015

Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-07-01, distributed in FL, NM, NY. IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the sh

Recall number	`Z-1843-2015`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States
Recall initiated	2015-05-06
Classified	2015-06-25
Reported by FDA	2015-07-01
Terminated	2016-06-22
Distributed	FL, NM, NY
Countries outside the US	AU, BE, CL, CR, CZ, DE, ES, FR, GR, GT, HR, IL, IT, JP, LV, MX, NL, PT, RO, SK
Reason classes	labeling, specification failure
Lot numbers	`206`
Model numbers	`T23L4`
Expiration dates	`2015-06-30`, `2015-11-30`

Product

IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. 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

IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label.

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-1843-2015. 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.