SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM — Class II medical device recall Z-0082-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-10-19, distributed nationwide. Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patie
| Recall number | Z-0082-2017 |
|---|---|
| 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 | 2016-08-24 |
| Classified | 2016-10-13 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2018-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BD, BG, BR, CN, CO, CR, CY, DE, EG, FR, GR, GT, ID, IL, IN, IT, MX, PL, PT, PY, RO, RS, SG, SK, UY, ZA |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414961996 |
| Lot numbers | 236M, 237, 238, 239, 239L |
| Model numbers | 10381327, L2KRM2 |
Product
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; 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
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.
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-0082-2017. 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.