Siemens IMMULITE Total IgE Assay Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling IMMULITE Total IgE assays due to a confirmed 23% positive bias against the WHO 2nd IRP 75/502.
What this means for you
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. The hazard is a systematic measurement bias (23% positive) which is a significant quality issue but does not involve a high-risk pathogen, structural defect, or reported injuries, fitting the Moderate category for low-risk contamination or labeling/measurement errors.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 5,953 units of the IMMULITE /IMMULITE 1000 Systems TIE Total IgE assay (REF LKIE1, SMN 10380867). The affected lots are numbered 326 through 333. These in vitro diagnostic products are used with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.
The recall was initiated because Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502. This bias indicates that the assay may produce results that are higher than the actual IgE levels in the patient's serum.
The affected products were distributed worldwide. Healthcare facilities and laboratories that have used or are using these specific lots should stop using them and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of
- Manufacturer
- Siemens Healthcare Diagnostics
- Hazard
- Affected units
- 5,953
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)
- Lots 326 through 333
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics 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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