Advanced Instruments Recalls GloCyte RBC Reagent Due to QC Failure
Advanced Instruments, LLC is recalling GloCyte RBC Reagent because high fluorescent counts cause quality control checks to fail, preventing patient sample testing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a functional failure preventing testing rather than a direct physical injury or contamination, fitting the Moderate criteria for low-risk operational issues.
Plain-English summary
Advanced Instruments, LLC is recalling GloCyte RBC Reagent, part number 111011, lot number R1513. The product is used in the GloCyte Automated Cell Counter System to determine the quantity of fluorescence-labeled total nucleated cells and erythrocytes in cerebrospinal fluid.
The recall was initiated due to a reagent failure where high fluorescent counts during the RBC Reagent and Diluent quality control check result in a failed QC check. This failure prevents users from testing patient samples for red blood cells (RBC).
The affected product was distributed in the United States in the states of Indiana, Washington, North Carolina, California, Georgia, and Colorado. Healthcare professionals using this product should stop using the affected lot and contact Advanced Instruments, LLC for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Advanced Instruments, LLC
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)
- Part number 111011
- Lot # R1513
Distribution
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