# FDA recall Z-2451-2023

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2023-07-25.

## Product

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151,  in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid

## Reason for recall

There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, CO, CT, FL, GA, IA, MD, MI, NJ, NM, NY, OH, PA, SD, TX, UT, and VA. Global distribution.

## Key facts

- **Recall number:** Z-2451-2023
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-25
- **Report date:** 2023-08-30

- **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-2451-2023

## Citation

> AI Analytics. FDA recall Z-2451-2023. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2451-2023. Source: US FDA. Licensed CC0.

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