Siemens ADVIA Centaur Calibrator C Recalled for Ferritin Assay Sensitivity Issues
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator C kits due to a realignment issue affecting ferritin assay sensitivity.
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, which typically involves a temporary or medically reversible adverse health consequence. The issue is a technical realignment affecting analytical sensitivity rather than a direct safety hazard like contamination or injury, fitting the Moderate severity criteria for low-risk technical defects.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,440 kits of the ADVIA Centaur Calibrator C. This in-vitro diagnostic product is used specifically with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system. The recall involves specific lot numbers ending in 22 and 23, with expiration dates ranging from January 19, 2013, to October 16, 2013.
The recall was initiated due to a realignment issue affecting the ferritin analytical sensitivity. The affected products were distributed worldwide, including in the United States and numerous international markets such as Argentina, Australia, Brazil, Canada, China, and others.
Healthcare facilities and laboratories should stop using the affected calibrator kits and contact Siemens Healthcare Diagnostics for instructions on return or replacement. Consumers are not directly affected as this is a professional in-vitro diagnostic product.
The recalled product
- Product
- ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 2,440
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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