Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 2/26/2020
Class II

PRODUCT

ADVIA Chemistry CardioPhase 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.

• Recall Number: Z-1260-2020

REASON

Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

844

DISTRIBUTION

US Nationwide and Worldwide