medical Class II Updated 2023-08-30

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP),

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00630414279176; Lot Numbers: All lots
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →