The Recall Desk

FDA (Devices) recall action 84413

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2020-02-26

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-02-26
Critical
0
Units
2,150

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-02-26

    Siemens Recalls ADVIA Chemistry CardioPhase hsCRP Calibrator Due to Accuracy Drift

    Siemens Healthcare Diagnostics is recalling 844 units of ADVIA Chemistry CardioPhase hsCRP Calibrator because accuracy has drifted from reference materials, causing high bias in quality control and patient sample recovery.

    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.
    Category
    Distribution
    37 states
  • ModerateFDA (Devices)··2020-02-26

    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.

    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
    Category
    Distribution
    37 states