Advanced Instruments, LLC: Medical Device Recall in 2018 - (Recall #: Z-0640-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 7, 2018

Date Posted: December 26, 2018

Recall Number: Z-0640-2019

Event ID: 79584

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.

Status: Terminated

Product Quantity:

Code Information:

Part number 111011, Lot # R1513

Distribution Pattern:

US Nationwide distribution in the states of IN, WA, NC, CA, GA, CO.

Voluntary or Mandated:

Voluntary: Firm initiated