Free Download Beckman Coulter Cell Counter Manual Programs For Weddings

воскресенье 25 августаadmin
Free Download Beckman Coulter Cell Counter Manual Programs For Weddings Rating: 8,5/10 9200 reviews
-

Beckman Coulter: Lab Equipment. Beckman Z1 Particle Counter Operator's Manual - Marshall Scientific by Marshall Scientific. Spread the word. Cell counting with the Beckman Z1 Coulter Counter Entered by Silvia LaRue Janes Lab Protocols 7/4/11 1 1. Turn on the Z1 by flipping the switch on the top left of the.

Free Download Beckman Coulter Cell Counter Manual Programs For Weddings
510(k)DeNovoRegistration & ListingAdverse EventsRecallsPMAHDEClassificationStandards
CFR Title 21Radiation-Emitting ProductsX-Ray AssemblerMedsun ReportsCLIATPLC

BECKMAN COULTER, INC. COULTER® ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELLBack to Search Results
Model Number ACT DIFF 2
Event Date 03/15/2011
Event Type Malfunction
Event Description

The bedtime story torrent. The customer contacted beckman coulter, inc. (bec) to report the coulter act diff 2 analyzer generated erroneous elevated platelet (plt) results with instrument generated flags for one (1) patient. The initial plt result of 142 was reported out of the laboratory. A rerun of the sample produced a plt result of 137. A manual slide was performed and the plt result was 39. The patient specimen was tested at a reference lab and also produced a plt result of 39. This result was considered to be correct. Initial and rerun results were flagged with instrument generated aperture and voteout flags that alert the operator to further review the sample. No death, injury or change to patient treatment was reported in connection with this customer feedback.

Manufacturer Narrative

Patient specimen was collected via venipuncture in a 3. 0 ml bd vacutainer tube. Quality control (qc) was run before but not after the reported incident and results were within qc specifications. The field service engineer (fse) checked qc results and found a high spike on the plt histogram for all three levels of controls. There was no noise or interference spike at the 2 fl mark on the plt histogram during background check and total background test was found to be within specifications. The fse replaced the aspiration probe, performed latex aperture current verification and the verified instrument performance. Instrument was validated and all tests passed within specifications. Per product labeling, if any flag appears, review the results according to your laboratory's protocol. An x flag indicates that one of the multiple aperture alert criteria was not met. A * flag/code indicates a questionable result. If on plt, mpv (pct and pdw) only, plt < 20 x 103/ul, or platelet distribution failure non-positive curve mode <3 or > 15 fl pdw > 20 voteout of fitted curve sweepflow error.

Search Alerts/Recalls

New Search Submit an Adverse Event Report

Type of DeviceCOUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
BECKMAN COULTER, INC.
11800 sw 147th avenue
miami FL 33196
Manufacturer (Section G)
BECKMAN COULTER, INC.
11800 sw 147th avenue
miami FL 33196
Manufacturer Contact
dung nguyen
250 s kraemer blvd
brea , CA 92821
7149614941
MDR Report Key2353930
Report Number1061932-2011-02414
Device Sequence Number1
Product CodeGKZ
Report Source Manufacturer
Source TypeHealth Professional,User facility
Reporter Occupation HEALTH PROFESSIONAL
Type of ReportInitial
Report Date03/16/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/01/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberACT DIFF 2
Device Catalogue Number6605500
OTHER Device ID NumberSW VERSION 2.01
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/16/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data