Siemens Recalls Atellica CH High Sensitivity C-Reactive Protein Calibrator
Siemens Healthcare Diagnostics is recalling Atellica CH High Sensitivity C-Reactive Protein Calibrators for in vitro diagnostic use.
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, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator. This product is intended for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase hsCRP assay.
The recall covers 1,306 units of the calibrator. The affected product is identified by Siemens Material Number (SMN)/REF 11099412, Lot Number 453716, and an expiration date of January 28, 2020. The UDI number is (01)00630414597508(10)453716(17)20200128.
Distribution was worldwide, including nationwide distribution in the United States and in numerous international countries. The source text does not specify the reason for the recall or any reported injuries or illnesses. Users should contact Siemens Healthcare Diagnostics for further instructions on how to handle the recalled product.
The recalled product
- Product
- Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,306
Distribution
Part of a larger recall action
This product is one of 2 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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