GloCyte RBC Reagent — Class II medical device recall Z-0640-2019
Terminated recall by Advanced Instruments, LLC, reported 2018-12-26, distributed nationwide. RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed
| Recall number | Z-0640-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Instruments, LLC, Norwood, MA, United States |
| Recall initiated | 2018-02-07 |
| Classified | 2018-12-19 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2019-09-24 |
| Distributed | Nationwide (US) |
| Lot numbers | R1513 |
| Model numbers | 111011 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0640-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.