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.
FDA Recall Z-0640-2019 · Posted None
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Recalling FirmAdvanced Instruments, LLC
Recall StatusTerminated
Product CodeGKL
Date Initiated2018-02-07
Date Terminated2019-09-24
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of IN, WA, NC, CA, GA, CO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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