# FDA recall Z-1260-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2019-11-19.

## 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.

## Distribution

Worldwide distribution  US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WY and countries of UK, CA, PH, MX, VN, TW, TH, IN, CO, AE, AR, AU, BD, BE, BG, BR, CL, CZ, DE, DK, EG, ES, FI, FR, GR, HU, IE, IT, KR, MY, NL, PL, PT, RO, RU, SE, SG.

## Key facts

- **Recall number:** Z-1260-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-19
- **Report date:** 2020-02-26
- **Termination date:** 2021-08-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1260-2020

## Citation

> AI Analytics. FDA recall Z-1260-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1260-2020. Source: US FDA. Licensed CC0.

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