medical Class II Updated 2020-02-26

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Cali

Recalled 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

Hazard / Issue

Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica¿ CH Analyzer.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Siemens Material Number (SMN)/REF: Atellica CH:11099412 Lot# 453716 Expiration Date: 2020-01-28 UDI Number: Atellica: (01)00630414597508(10)453716(17)20200128
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