Recall Z-0640-2019 ยท GKL Counter, Cell, Automated (Particle Counter)
Advanced Instruments, LLC
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
| Date | Feb 7, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Distribution | US Nationwide distribution in the states of IN, WA, NC, CA, GA, CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152776 | Glocyte Automated Cell Counter System Advanced Instruments, Inc., May 27, 2016 |