ADVIA Chemistry Urinary Protein Reagent Carryover Causing Incorrect Creatinine Results
A reagent carryover issue in Siemens ADVIA Chemistry urinary protein test kits can cause falsely low creatinine test results. The problem occurs when the creatinine test is run after the protein test on the same system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a diagnostic reagent with confirmed risk of producing falsely depressed test results that could affect patient care decisions. No illnesses or injuries have been reported. The hazard is confirmed but actual clinical impact has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) reagent kits, Material Number 11319151, all lots. Approximately 3,067 units were distributed worldwide, including in the United States.
The recall addresses a potential for reagent carryover from the UCFP test that can impact the Enzymatic Creatinine_2 (ECRE_2) test when performed on the same ADVIA Chemistry analyzer system. If the creatinine test is run after the protein test, falsely depressed (lower than actual) creatinine results may be observed.
Affected facilities include clinical laboratories, hospitals, and diagnostic centers using this reagent in the United States (CA, CO, CT, FL, GA, IA, MD, MI, NJ, NM, NY, OH, PA, SD, TX, UT, VA) and in other countries worldwide.
The recalled product
- 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
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,067
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00630414279176
- Lot Numbers: All lots
Distribution
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