Recall Z-1260-2020— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1260-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-19

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2019-11-19, terminated 2021-08-30. It names one FDA 510(k) clearance: K081294. 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.. 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: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-11-19
Terminated: 2021-08-30
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K081294 — ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORSSiemens Healthcare Diagnostics, Inc.·cleared 2008-07-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.