GloCyte RBC Reagent recalled by Advanced Instruments

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide CaliforniaColoradoGeorgiaNorth CarolinaWashington