ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein — Class II medical device recall Z-1260-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-02-26, distributed nationwide. Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), w
| Recall number | Z-1260-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2019-11-19 |
| Classified | 2020-02-18 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2021-08-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 844 |
| UPC / GTIN / UDI-DI | 00630414526843 |
| Lot numbers | 2020-01, 453610 |
| Model numbers | 05006455 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1260-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.