Siemens Recalls ADVIA Centaur Insulin Assay Kits Due to Accuracy Issues
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Insulin ReadyPacks because the assay results are approximately 40% higher than the WHO standard. The company states the overall risk to health is negligible.
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 source explicitly states that the overall risk to health is negligible and that the manufacturer does not recommend reviewing previous results, which aligns with the rubric for voluntary precautionary recalls or low-risk issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the ADVIA Centaur Systems Insulin ReadyPack (Test Code: IRI; Catalog Number: 02230141). The affected products are used for in vitro diagnostic testing to quantitatively determine insulin levels in serum. The recall includes kit lots ending in 169, 170, 173, and 174.
The recall was initiated because current lots of the assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met according to the assay Instructions for Use.
The products were distributed in the United States and numerous countries outside the US. Siemens states that the overall risk to health is negligible and is not recommending a review of previously generated results.
The recalled product
- Product
- ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.
- 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 (4)
- Kit Lots Ending: 169
- 170
- 173
- 174
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, 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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