Reported Dec 26, 2018 · Terminated
GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained…
Advanced Instruments, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Instruments, LLC · 2 Technology Way · Norwood, MA · 02062-2633
Is this the product you have?
- GloCyte RBC Reagent - Product UsageThe 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
- Lot codes and dates
Part number 111011Lot # R1513
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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