Recall Z-0640-2019— Advanced Instruments, LLC

Name: FDA recall Z-0640-2019
Creator: U.S. Food and Drug Administration
Published: 2018-02-07

Class II · Terminated

Class II FDA medical device recall by Advanced Instruments, LLC, initiated 2018-02-07, terminated 2019-09-24. It names one FDA 510(k) clearance: K152776. 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.. 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..

Recalling firm: Advanced Instruments, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-02-07
Terminated: 2019-09-24
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K152776 — Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.·cleared 2016-05-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.