# FDA recall Z-2474-2023

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2023-07-10.

## Product

Atellica¿  CH HDL Cholesterol- In vitro diagnostic use in the  quantitative determination of HDL cholesterol in human serum and plasma (lithium  heparin, EDTA, sodium Heparin)   Test Code: HDLC  Siemens Material Number (SMN): 11537213

## Reason for recall

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with  from Atellica¿  CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿  CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)

## Distribution

US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam

## Key facts

- **Recall number:** Z-2474-2023
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-10
- **Report date:** 2023-09-06

- **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-2474-2023

## Citation

> AI Analytics. FDA recall Z-2474-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2474-2023. Source: US FDA. Licensed CC0.

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