Siemens Recalls ADVIA Centaur CKMB Calibrator Kits Due to Potential Bias
Siemens Healthcare Diagnostics is recalling 1,870 ADVIA Centaur CKMB Calibrator kits due to a potential bias 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 hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,870 kits of the ADVIA Centaur CKMB Calibrator, Catalog No. 09318028. The product is intended for in vitro diagnostic use in calibrating CKMB assays on ADVIA Centaur systems.
The recall was initiated because a potential bias was identified with certain kits when compared to the internal standards. The affected products were distributed nationwide in the United States.
Hospitals and laboratories should stop using the affected calibrator kits and contact Siemens Healthcare Diagnostics for further instructions. The specific lot numbers and expiration dates are listed in the agency's recall record.
The recalled product
- Product
- ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 1,870
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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