# FDA recall Z-2430-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-06-05.

## Product

ADVIA Chemistry Calibrator

## Reason for recall

Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2430-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-05
- **Report date:** 2020-07-01
- **Termination date:** 2021-11-18

- **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-2430-2020

## Citation

> AI Analytics. FDA recall Z-2430-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2430-2020. Source: US FDA. Licensed CC0.

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