Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Recalled by Advanced Instruments, LLC Due to RBC Reagent failure. High fluorescent counts during RBC...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Advanced Instruments, LLC directly.
Affected Products
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.
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Advanced Instruments, LLC
Advanced Instruments, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report