Siemens Recalls Insulin Calibrators Due to Measurement Deviation
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Insulin Calibrators because they measure approximately 40% higher than the WHO standard.
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 source explicitly states the overall risk to health is negligible and no review of previous results is recommended, fitting the criteria for a voluntary precautionary recall or low-risk issue.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of ADVIA Centaur Systems Insulin Calibrators (Test Code: Calibrator IRI; Catalog Number: 04618899). The affected lots are identified by lot numbers ending in 59, 67, 70, and 74. These products were distributed in the United States and numerous countries internationally.
The recall was initiated because current lots of the ADVIA Centaur/XP/XPT/CP Insulin (IRI) 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 per the assay Instructions for Use.
The source text states that the overall risk to health is negligible. Siemens is not recommending a review of previously generated results.
The recalled product
- Product
- ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
- 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: 59
- 67
- 70
- 74
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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