Z-1843-2015Class II

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

Name: Z-1843-2015 IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-05-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-05-06 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use... on 2015-05-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1843-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-06
Posted: 2015-06-25
Terminated: 2016-06-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: DHB System, Test, Radioallergosorbent (Rast) Immunological
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Siemens Healthcare Diagnostics issued an Urgent Medical Device Recall Letter (IMC-15-11A.US, dated May 6, 2015) in the US via FedEx, and an Urgent Field Safety Notice (IMC-15-11A.OUS, May 2015) outside the US on May 6, 2015. Customers were instructed to immediately discontinue use of and discard IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 206. The shelf-life of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 208, has been shortened to June 30, 2015. Discontinue use and discard lot 208 after June 30, 2015. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days in the US and OUS and fax to Customer Care Center at 312-275-7795.
Quantity in commerce: Domestic: 17 kits, Foreign: 1549 kits
Distribution: 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.
Product codes and lots: Kit lots 206 (exp. 6-30-2015) and 208 (exp. 11-30-2015)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1843-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1843-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25

Product code DHB

K013134Class IIImmulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2kun6 (600 Tests)Diagnostic Products Corp. / cleared 2001-10-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)