Advanced Instruments recalls GloCyte RBC Reagent due to high fluorescent counts causing failed QC checks, preventing accurate patient sample testing in clinical labs.
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.
Advanced Instruments recalls GloCyte RBC Reagent because it fails quality control checks, which could prevent accurate testing of patient samples. This affects clinical laboratories using the system for cerebrospinal fluid analysis.
The reagent causes high fluorescent counts during quality control checks, which leads to failed QC tests. This prevents healthcare workers from accurately testing patient cerebrospinal fluid samples for red blood cells.
Healthcare professionals in clinical laboratories using the GloCyte Automated Cell Counter System for cerebrospinal fluid testing are most affected. The recall impacts patients whose samples cannot be tested due to failed quality checks.
Check for the GloCyte RBC Reagent with part number 111011 and lot number R1513. The product is used in clinical laboratories with the GloCyte Automated Cell Counter System.
Identify the lot number on the reagent container to confirm if it's affected (lot R1513).
The reagent causes high fluorescent counts during quality control checks, which prevents accurate patient sample testing.
The recall record does not specify a remedy, so no action is required beyond checking the lot number.
The recall indicates it may cause failed quality checks, but the record does not specify if it's unsafe for normal use.
We’ve drafted a message you can send Advanced Instruments to request your refund or repair — edit it as you like.
Subject: Recall Z-0640-2019 — Advanced Instruments Advanced Instruments Hello, I own a Advanced Instruments that is covered by recall Z-0640-2019 from Advanced Instruments. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
