Siemens Recalls IMMULITE 2000 Total IgE Assays Due to Positive Bias
Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 2000 Total IgE assays because they show a 23% positive bias against the WHO standard.
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 error (positive bias) that could lead to inaccurate diagnostic results, but the source text does not report any specific patient injuries, illnesses, or deaths.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 18,489 units of IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE assays. The affected products include reference numbers L2KIE2 (SMN 10380873) and L2KIE6 (SMN 10380872), specifically lots 260 through 275. These in vitro diagnostic (IVD) products are used for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum on IMMULITE, IMMULITE 1000, and IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers.
The recall was initiated because Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 standard. This bias means the assays may report higher IgE levels than actually present in the patient's serum.
The affected units were distributed worldwide. Healthcare facilities and laboratories using these specific lots should stop using the assays and contact Siemens Healthcare Diagnostics for instructions on how to return the products.
The recalled product
- Product
- IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers
- Manufacturer
- Siemens Healthcare Diagnostics
- Affected units
- 18,489
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 260 through 275
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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