Reported Oct 19, 2016 · Terminated
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
3 of 3 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 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 | |
| 2 | 00630414961996 | Unique Device Identification Number (UDI) 00630414961996 |
| 3 | 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 |
- Lot codes and dates
Kit lots 236M237238239239L (OUS) and D236M and D238 (US)
- Amount recalled
- Domestic: 177 Kits; Foreign: 3435 Kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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