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U.S. Department of Health and Human Services

Class 2 Device Recall GloCyte Automated Cell Counter System GloCyte Low and High Level Controls

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  Class 2 Device Recall GloCyte Automated Cell Counter System GloCyte Low and High Level Controls see related information
Date Initiated by Firm February 07, 2018
Create Date December 19, 2018
Recall Status1 Terminated 3 on September 24, 2019
Recall Number Z-0640-2019
Recall Event ID 79584
510(K)Number K152776  
Product Classification Counter, cell, automated (particle counter) - Product Code GKL
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 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.
Code Information Part number 111011, Lot # R1513
Recalling Firm/
Manufacturer		 Advanced Instruments, LLC
2 Technology Way
Norwood MA 02062-2633
For Additional Information Contact
781-320-9000
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GKL and Original Applicant = Advanced Instruments, Inc.
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