Siemens Recalls ADVIA Centaur Ferritin Calibrator C Due to Analytical Sensitivity Issues
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Ferritin Calibrator C kits due to realignment issues with specific kit lots. The recall affects 8,263 kits distributed worldwide.
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, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report any specific injuries, illnesses, or deaths, and the issue is related to analytical sensitivity and calibrator realignment rather than a direct physical hazard like fire or choking.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 8,263 kits of the ADVIA Centaur Ferritin Calibrator C. This in-vitro diagnostic product is used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system. The recall is due to Ferritin Analytical Sensitivity and Calibrator C Realignment issues associated with kit lots ending in 22 and 23.
The affected products are identified by Catalog Number 03439230 (2 pack). Specific lot numbers involved include 82052A22, 82335A22, 82909A22, 85268A22, 86701B22, 88921B22, 89956B22, 90925B22, 91336B22, 95231A23, and 95553A23. Some lots have expiration dates of 01/19/2013 and 01/16/2013.
The recall covers nationwide distribution in the United States as well as international distribution in countries including Argentina, Australia, Brazil, Canada, China, Colombia, Egypt, Hong Kong, India, Israel, Indonesia, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Vietnam, and South Africa. Users should stop using the affected calibrator kits and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 8,263
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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