Z-0081-2017Class II

SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material...

Name: Z-0081-2017 SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-08-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-08-24 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device... on 2016-08-24. FDA classified it as Class II and gives the reason as "Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0081-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-24
Posted: 2016-10-13
Terminated: 2018-05-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
Product code: LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Reason for recall: Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.
FDA root cause: Under Investigation by firm
Action: Siemens sent an Urgent Medical Device Recall Letter IMC16-20.A.US , dated August 24, 2016, to the US consignees via FedEx, and an Urgent Field Safety Notice IMC16-20.A.OUS (dated August 2016) was sent to foreign representatives for distribution to foreign consignees. Customers were instructed to discontinue use of and discard the affected kit lots. Customers were also requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For questions, customers were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative.
Quantity in commerce: Foreign: 359 Kits
Distribution: Worldwide Distribution n- US (Nationwide) and Foreign distribution to the following countries: Argentina, Bangladesh, Brazil, Bulgaria, China, Colombia, Costa Rica, Cyprus, Egypt, France, Germany, Greece, Guatemala, India, Indonesia, Israel, Italy, Kazakhstan, Macedonia, Mexico, Paraguay, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Syria, United Arab Emirates, and Uruguay.
Product codes and lots: Kit lots 0333 and 0334 (OUS)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0081-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0081-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13
Z-0082-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13

Product code LFX

K012077Class IIImmulite Rubella Igm,lkrm1, Lkrm2, Immulite 2000 Rubella Igm, Model L2krm2, L2krm6Diagnostic Products Corp. / cleared 2002-01-10

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)