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.
Recall
- Recall Number
- Z-0640-2019
- Event Number
- 79584
- Firm
- Advanced Instruments, LLC
- FEI Number
- 1217058
- Product Code
- GKL
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- February 7, 2018
- Terminated
- September 24, 2019
- Address
- 2 Technology Way, Norwood, MA, 02062-2633
Description
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.
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.
Customers have been sent a recall notification communicating the reason for recall. Once a root cause is identified, recalling firm will notify customers and make available new RBC Reagent lots to allow customers to resume use of reagent in RBC counting.
US Nationwide distribution in the states of IN, WA, NC, CA, GA, CO.