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Involves only a single cell type or a diverse cell population, the Z series analyzers are the instruments of choice for your cellular applications. The Beckman Coulter Technology Center The History of Beckman Coulter. Z1, z2, coulter counter, cell counting, cell sizing.

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Beckman Coulter UniCel® DxH 800 COULTER@ Cellular Analysis System 1.0 Submitted By. 21 CFR § 864.5220 -Automated differential cell counter Classification: Class 11 Product Code: GKZ. Blood Count MCV, MCH, MCHC, ROW, Whole Blood * Manual Single Tube Closed Vial (CBC) RDW-SD, PLI', MPV * Manual Single Tube Open Vial CBC.
Home > Cell Counters > Automated Cell Counters > Z Series Coulter Counter® Cell and Particle Counters, Beckman Coulter® Z Series Coulter Counter® Cell and Particle Counters, Beckman Coulter®. Z1™ Single Threshold Coulter Counter®.

BECKMAN COULTER, INC. COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL

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Model Number LH 500

Event Date 09/12/2011

Event Type Malfunction

Manufacturer Narrative

The customer failed a cap (college of american pathologists) survey; however, qc run before and after the event recovered within range. Erroneous ba result only occurred on patient sample. A field service engineer (fse) replaced the needle cartridge, and the elyse and slyse pump, and ran diff latron calibration. The fse verified repair per established procedures and results meet published performance specifications. The problem with high ba was resolved. The root cause is attributed to an elyse and slyse pump malfunction which caused a chemical imbalance. The following mdr numbers are associated with this event: 1061932-2011-01741, 1061932-2011-01742, 1061932-2011-01743, 1061932-2011-01744.

Event Description

A customer contacted beckman coulter inc. , (bec), and reported that the coulter lh 500 hematology analyzer generated an erroneous high basophils (ba) result without instrument generated flags on one patient sample. The customer questioned the result due to user-defined flag and a message for the ba parameter. Customer performed a manual smear and ba% result was lower. No incorrect result was reported outside of the lab and there was no change to patient treatment.

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Type of Device

COUNTER, DIFFERENTIAL CELL

Manufacturer (Section D)

BECKMAN COULTER, INC.

11800 sw 147th avenue

miami FL 33196

Manufacturer (Section G)

BECKMAN CULTER INC.

11800 sw 147th avenue

miami FL 33196

Manufacturer Contact

nora zerounian

250 s. kraemer blvd.

brea , CA 92821

7149613634

MDR Report Key

2297389

Report Number

1061932-2011-01740

Device Sequence Number

Product Code

GKZ

Report Source

Manufacturer

Source Type

User facility

Reporter Occupation

Type of Report

Initial

Report Date

09/15/2011

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

Date FDA Received

10/15/2011

Is This An Adverse Event Report?

Is This A Product Problem Report?

Yes

Device Operator

HEALTH PROFESSIONAL

Device MODEL Number

LH 500

Device Catalogue Number

178833

Device LOT Number

N/A

Was Device Available For Evaluation?

Yes

Date Manufacturer Received

09/15/2011

Was Device Evaluated By Manufacturer?

Yes

Date Device Manufactured

07/01/2007

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Unkown

Removal/Correction Number

N/A

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Contact Us | Beckman Coulter

We have received your inquiry and will contact you shortly with the information you requested. Request More Information. ... I consent to receiving information about Beckman Coulter webinars, products, goods, and services, including similarly related products, ... Cell Counters & Analyzers

Cell Counters and Analyzers - Beckman Coulter

Free Download Beckman Coulter Cell Counter Manual Programs For Single Person

Cell Counters, Sizers and Media Analyzers. Since the invention of the original COULTER COUNTER in 1954, we have built a full family of innovations that streamline cell counting, sizing, viability analysis and cell culture monitoring systems-thereby opening up new possibilities for you in life sciences.

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Support | Beckman Coulter

Find support for questions and issues related to your Beckman Coulter products or services. English ... you will receive a reminder email containing the details of your Scheduled Order. Select the Confirm option within the reminder email and complete the checkout process to submit your order. ... Cell Counters & Analyzers

Company History - Beckman Coulter

Coulter Corporation was founded by Wallace and Joseph Coulter in 1958 as a private company, remaining under the control of the Coulter family until acquired by Beckman Instruments, Inc. in 1997. Coulter marketed the Coulter Counter, an instrument used to determine the distribution of red and white cells in blood.

Vi-CELL XR, Cell Counter - Beckman Coulter

Vi-CELL XR. The Vi-CELL ™ Cell Viability Analyzer provides an automatic means to perform the Trypan Blue Dye Exclusion method, allowing users to load up to 9 samples at once for easy and automated cell analysis. Vi-CELL software offers pre-programmed and customizable analysis options for consistent and accurate analysis of simple cell systems or your own cell line.

Reference Manual - usf.edu

r Contact is made with moving parts. r Broken Parts are disposed of incorrectly. r Doors, covers, and panels are not opened, closed, removed and/or replaced with ... Beckman Coulter provides the Vi-CELL XR software and operating system software where ... Cell Count: the actual number of cells recorded per frame and for the total number of frames.

FDA alerts hospitals, laboratories and health care ...

FDA News Release. FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results

Beckman Coulter Vi-Cell XR Cell Counter - The Lab World Group

The Beckman Coulter Vi-Cell XR Cell Counter uses a smart technology with automated cell staining and quantitation. Custom applications may be used on simple systems like CHO cells or more complex cells like yeast. Incorporated into the Vi-Cell software is a cell function, and the means configure the cell counter for many different cell species ...

Product History Timeline - Beckman Coulter

Product Timeline Beckman Coulter Product Milestones in History. 1930s 1935 Model E pH Meter — First Beckman pH Meter (sold approximately 350,000 Models E, F, and G over next 50 years)

Contactez-nous - Beckman Coulter

Beckman Coulter France SAS Paris-Nord 2 22, Av. des Nations B.P. 54359 – Villepinte 95942 Roissy CDG Cedex Téléphone: +33 149-909-261 Email: [email protected] Coordonnées des commerciaux et des contacts Service et Assistance

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