Z-1518-2014Class II

IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872...

Name: Z-1518-2014 IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872...
Creator: Siemens Healthcare Diagnostics
Published: 2013-12-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-12-20 / Terminated

FDA source

Siemens Healthcare Diagnostics began a recall of IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products... on 2013-12-20. FDA classified it as Class II and gives the reason as "Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1518-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-20
Posted: 2014-04-25
Terminated: 2018-05-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.
Product code: JHR Radioimmunoassay, Immunoglobulins (D, E)
Reason for recall: Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Correction Letters (dated 12/20/13) and effectiveness check response forms were sent to customers on 12/20/13 via FedEx to inform them of the issue. Customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent a support document describing the issue and instructing them how to deal with customer questions.
Quantity in commerce: 18,489 units
Distribution: Worldwide distribution.
Product codes and lots: Lots 260 through 275

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1518-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1517-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-25
Z-1518-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-25

Product code JHR

K931703Class IIImmulite Total IgeDiagnostic Products Corp. / cleared 1993-08-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)