Z-0640-2019Class II

GloCyte RBC Reagent -

Name: Z-0640-2019 GloCyte RBC Reagent -
Creator: Advanced Instruments, LLC
Published: 2018-02-07
License: https://open.fda.gov/license/

Advanced Instruments, LLC / initiated 2018-02-07 / Terminated / root cause: design

FDA source

Advanced Instruments, LLC began a recall of GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories... on 2018-02-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0640-2019
Classification: Class II
Status: Terminated
Initiated: 2018-02-07
Posted: 2018-12-19
Terminated: 2019-09-24
Recalling firm: Advanced Instruments, LLC
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.
Product code: GKL Counter, Cell, Automated (Particle Counter)
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Part number 111011, Lot # R1513

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0640-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0640-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-19

Product code GKL

K152776Class IIGlocyte Automated Cell Counter SystemAdvanced Instruments, Inc. / cleared 2016-05-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)