Siemens Atellica IM CKMB Master Curve Material Recalled for Potential Bias
Siemens Healthcare Diagnostics is recalling Atellica IM CKMB Master Curve Material due to a potential bias identified when 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential bias in diagnostic results, which fits the criteria for a moderate severity recall involving low-risk contamination or precautionary measures without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling two sets of Atellica IM CKMB Master Curve Material, Catalog Number 10995534. The product is intended for in vitro diagnostic use to evaluate the ADVIA Centaur CKMB assay. The specific lot number is 11803, with an expiration date of February 10, 2019.
The recall was initiated because a potential bias was identified with certain kits compared to the internal standards. The product was distributed nationwide in the United States.
Healthcare facilities and users of the product should stop using the affected material and contact Siemens Healthcare Diagnostics for further instructions or a return.
The recalled product
- Product
- Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 2
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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