Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2451-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 25, 2023

Date Posted: August 30, 2023

Recall Number: Z-2451-2023

Event ID: 92808

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.

Status: Ongoing

Product Quantity: 3067 units

Code Information:

UDI-DI: 00630414279176; Lot Numbers: All lots

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated