Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1532-2014·Announced 2014-05-07

Siemens Androstenedione Assay Recall Due to Over-Recovery

Siemens recalls Androstenedione assays because they over-recover samples above 5.5 ng/mL, contradicting the stated 10 ng/mL 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: The recall is classified as FDA Class II, but the hazard involves a specific analytical limitation (over-recovery above 5.5 ng/mL) rather than a broad safety failure or reported injuries, fitting the criteria for a moderate severity recall.

Plain-English summary

Siemens Healthcare Diagnostics is recalling the IMMULITE 2000/2000 XPi Systems Androstenedione assays (Test Code AND, REF L2KAO2, SMN 10381188). The recall involves 7,741 units of the 200 test kit size, specifically Lot Numbers 314 and above. These products were distributed worldwide, including the United States and various international markets.

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.

Healthcare facilities and laboratories using these assays should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions. The issue affects the quantitative measurement of 4-androstenedione in human serum.

The recalled product

Product: IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 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
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
analytical-error
Affected units: 7,741

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 314 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.

See all 2 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics

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Same hazard · mis labeling