Siemens CMV IgM Assay Recalled for Increased Imprecision
Siemens Healthcare Diagnostics is recalling IMMULITE CMV IgM Assay kits due to reported increases in imprecision and high coefficient of variation (CV) values.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a performance issue (imprecision) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the IMMULITE/IMMULITE 1000 Systems CMM CMV IgM Assay. The recall involves 5 kits in the United States and 372 kits distributed internationally. The affected products are identified by UDI 00630414985718 (Catalog # LKCM1(D)) and UDI 00630414963747 (Catalog # LKCM1), with specific kit lots D0330, 0330, and 0331.
The recall was initiated after multiple customers reported an increase in imprecision with the assay. This issue resulted in high percentage coefficient of variation (% CVs) for some patients. The problem was observed starting with reagent lots 259 and above.
The affected kits were distributed worldwide, including nationwide in the United States and in numerous other countries. The product is intended for in vitro diagnostic use to detect IgM antibodies to Cytomegalovirus (CMV) in human serum or plasma. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 (3)
- UDI 00630414985718/Catalog # LKCM1(D): Kit lot D0330
- UDI 00630414963747/Catalog # LKCM1: Kit lots 0330
- 0331
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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