Siemens Rubella IgM Assay Recalled for False Positive Results
Siemens is recalling specific lots of Rubella IgM assays due to increased false positive and indeterminate results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical diagnostic device with reported performance issues (false positives/indeterminate results) that could lead to incorrect clinical decisions, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM) assay. The recall involves 177 kits distributed in the United States and 3,435 kits distributed internationally. The affected lots are 236M, 237, 238, 239, and 239L for international markets, and D236M and D238 for the US market.
The recall was initiated after Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results, as well as increased imprecision. The product is an in vitro diagnostic used for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma, serving as an aid in the presumptive diagnosis of acute or recent rubella infection.
The affected kits were distributed nationwide in the US and to numerous foreign countries including Argentina, Brazil, China, France, Germany, India, and Italy. Healthcare facilities and laboratories should stop using the affected lots and contact Siemens for further instructions.
The recalled product
- 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
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Kit lots 236M
- 237
- 238
- 239
- 239L (OUS) and D236M and D238 (US)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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