Siemens ADVIA Centaur CKMB Calibrator Recalled for Potential Bias
Siemens Healthcare Diagnostics is recalling 69 kits of ADVIA Centaur CKMB Calibrator 2-pack Japan due to a potential bias identified compared to internal standards.
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, and the source text describes a 'potential bias' without reporting any specific injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 69 kits of the ADVIA Centaur CKMB Calibrator 2-pack Japan, Catalog No. 02562748. The product is intended for in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
The recall was initiated because a potential bias was identified with certain kits compared to the internal standards. The affected lots are 58311A67 and 97468A67, both with an expiration date of December 11, 2018. The products were distributed nationwide in the United States.
Healthcare facilities and laboratories should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions. Consumers are not directly affected as this is a professional in vitro diagnostic product.
The recalled product
- Product
- ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 69
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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