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FDAJuly 25, 2023device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

00630414279176

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear