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Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume
Advanced Instruments, LLC · Model 806054 · UDI-DI 00816068020009
GKL
Prescription
1
510(k) clearances
215
Adverse events
10
Recalls
21
Facilities
Description
For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Used for aspirating and dispensing sample and reagents.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-02-07 | Advanced Instruments, LLC | 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. |
| 2016-03-18 | Becton, Dickinson and Company, BD Biosciences | The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instructions for Use are c |
| 2014-12-19 | BD Biosciences, Systems & Reagents | One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data. |
| 2013-06-26 | Siemens Healthcare Diagnostics | The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached |
| 2011-01-31 | Beckman Coulter Inc. | This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). Starting Jan 1, 2011, |
| 2007-04-18 | Beckman Coulter Inc | Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. |
| 2006-03-16 | Bayer Healthcare, LLC (Diagnostics Division) | The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an ab |
| 2004-02-13 | Beckman Coulter Inc | Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print |
| 2004-02-13 | Beckman Coulter Inc | Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print |
| 2004-02-13 | Beckman Coulter Inc | Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.