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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