FDA-Device2023-08-30Class II
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
Siemens Healthcare Diagnostics, Inc.
Hazard
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.
Sold states
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.
Affected count
3067 units
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2451-2023Don't want to check this manually?
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