ADVIA® Chemistry CardioPhase™ hsCRP Calibrators 10335897Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K081294); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 19, 2019Class IITerminated

   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.

   Z-1260-2020 · Root cause: No Marketing Application · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081294. One submission often covers many models, so check the product and lot details in each record.

• Z-1261-2020 · Nov 19, 2019 · Terminated
  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 hs