Counter, Cell, Automated (particle Counter)

CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046.

One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.

ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 .

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 to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures.

Coulter GEN's

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, the date fields will transmit as a blank field to the LIS if the year is greater than 2010. The following dates are affected: Run date, Control expiration date, Date of birth (For individuals born in 2011 or later), a

COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)

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. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2)- When manually entering a Patient ID, if a blank space is entered between th

ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter

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 abnormal baso cytogram.

CXP software, Part No. 623560, version 1.0

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 format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.

Cytomics MXP Software, Version 1.0, Part No. 623688.

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 format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.

Cytomics RXP Software, Version 1.0, Part Numbers:

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 format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.

GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories

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.

BD-Retic-Count Reticulocyte Reagent System;

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 correct.