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Recall Observatory FDA recall evidence

Device 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.

Z-1843-2015

May 06, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 71363
Status
Terminated
Classification
Class II
Quantity
Domestic: 17 kits, Foreign: 1549 kits
Official record key
device-enforcement:Z-1843-2015

Official wording

Reason: 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.

Code information: Kit lots 206 (exp. 6-30-2015) and 208 (exp. 11-30-2015)

Distribution pattern: Worldwide Distribution-Distributed in the states of Florida, New Mexico and New York and the countries of Australia, Belgium, Chile, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, Guatemala, Israel, Italy, Japan, Kazakhstan, Latvia, Netherlands, Portugal, Romania, Russian Federation, Slovakia, and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.