Siemens Recalls Rubella IgM Assay Kits Due to False Positive Results
Siemens is recalling specific lots of Rubella IgM assay kits because they may produce false positive or indeterminate results on certain analyzers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device that may produce false positive or indeterminate results, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM) assay kits. The recall affects kits with lot numbers 0333 and 0334, which are intended for in vitro diagnostic use to detect IgM antibodies to Rubella virus in human serum or plasma.
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. These issues were observed for several lots of the Rubella IgM assay when used on the IMMULITE 2000 and IMMULITE 2000 XPi platforms.
The affected kits were distributed worldwide, including nationwide in the United States and in various foreign countries. Users of these specific kits should stop using them and contact Siemens Healthcare Diagnostics for further instructions or replacement.
The recalled product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 359
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 (1)
- Kit lots 0333 and 0334 (OUS)
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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