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