Advanced Instruments, LLC recalls GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcar…

Recall date

February 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0640-2019

FDA classification

Class II

Brand / firm

Advanced Instruments, LLC

Sold / distributed

US Nationwide distribution in the states of IN, WA, NC, CA, GA, CO.

Why it was recalled

RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes.