Siemens IMMULITE Androstenedione Assay Recalled for Over-Recovery
Siemens recalls IMMULITE Androstenedione assays because they over-recover samples above 5.5 ng/mL, contradicting the stated 10 ng/mL linearity limit.
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: This is an FDA Class II recall involving a labeling/accuracy discrepancy where the stated linearity limit in the IFU is incorrect, but no specific patient injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics is recalling IMMULITE/IMMULITE 1000 Systems Androstenedione assays (Test Code AND, REF LKAO1) and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (REF L2KAO2). The recall affects 892 units of the 100-test kit size, specifically Lot Numbers 409 and above.
The recall was initiated because Siemens confirmed that the assays over-recover samples with concentrations greater than 5.5 ng/mL. The manufacturer determined that the lots are linear only up to 5.5 ng/mL, rather than the 10 ng/mL limit stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue.
The affected products were distributed worldwide, including nationwide in the United States and in countries such as Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Estonia, France, Germany, Great Britain, Italy, New Zealand, Portugal, Spain, Switzerland, Turkey, and Vatican City. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems…
- Manufacturer
- Siemens Healthcare Diagnostics
- Affected units
- 892
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)
- Lot Numbers 409 and above
Distribution
Distributed nationwide across the United States.
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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