Urgent Field Safety Notice Urgent Field Safety Notice
Contents
1. C Attachment 1 04 08 2010 LI AISON Instrument I nitialization Procedure Dear User The purpose of this document is to supply further information about the LIAISON initialization procedure in particular it is highlighted the correct way to Interact with the analyzer while it Is initializing after having switched it on or after a routine aborting User Documentation References e User Manual Chapter 4 2 3 Starting the system on at the beginning of the working week Chapter 4 2 4 Starting the system on after a period of three or more days of inactivity e Quick Guide Chapter 4 1 Switching on the system The current document represents a clarification on the information already contained in the LIAISON User Manual and in the LIAISON Quick Guide according to Software Version 2 28 The next manuals revision will include the below mentioned details Instrument initialization Here below it is resumed the correct procedure to achieve a correct instrument initialization Prior performing the instrument initialization ensure that all covers are placed in the original positions and both the flaps Sample area and reagents bay are closed During the whole initialization procedure the user must not interact with any parts of the instrument itself e g Opening flaps exchanging bottles etc The instrument shall be left untouched until the sequence Is finished The initialization procedure can occur upon diff2. DiaSorin S p A Via Crescentino snc 13040 Saluggia VC Italy i tel 39 0161 487093 The Diagnostic Specialist ex SOIL tebe www diasorin com DiaSorin Urgent Field Safety Notice Urgent Field Safety Notice Commercial name of the affected products LIAISON Analyzer FSCA identifier e g date August 3 2010 Date August 3 2010 Attention Carefully read the information given in this Field Safety Notice Details on affected device Type of device In Vitro Diagnostic Medical Device Model name LIAISON Catalog 9450200 and LIAISON LAS Catalog 10041 Batch serial number All serial numbers Expiry date N A Description of the problem An investigation performed on the LIAISON Analyzers confirmed the following issue 1 During the System Initialization and exactly when the pipettors are washing if either patient sample or reagent area flap door are opened the shaker rod may stop moving ll This event will affect the suspension of magnetic particles leading to a string of low RLU values for calibrators controls and patient samples ill A sequence of false positive or negative results or incorrect dose may be experienced depending on the assay scheme The frequency of occurrence is anticipated to be very rare due to the limited time span few seconds in which these actions could potentially occur simultaneously The ability to detect the issue 1s also considered to be very high since magnetic
3. Fassio Corporate Quality Assurance and Regulatory Affairs Director DI ASORIN S p A Page 2of 3 DiaSorin S p A Via Crescentino snc 13040 Saluggia VC Italy rae tel 39 0161 487093 The Diagnostic Specialist E www diasorin com DiaSorin This section has to be filled in by the customer and returned to DiaSorin S p A RETURN TO FAX No 39 0161 487 940 ATTN Ms ROSY VIRZI QUALITY ASSURANCE RETURN BY MAIL TO DiaSorin S p A ATTN Ms ROSY VIRZI QUALITY ASSURANCE Via Crescentino snc 13040 Saluggia VC Italy I the undersigned have received the above Filed Safety Notice I confirm I have read and understood the provisions as stipulated by DiaSorin Name incapital letters dss pecesonsatettaacavcccnerdesasaassucncousatediaacaccasnesseaaseussecneossodd Positon Held qj O O sesassarenengueassearininesstaceamannienmeusaueaasaneuenesebadsemsaruenmesbadeds Hospital Establishment nae Een AR eei Dep E A A A OER AA E E E A E E E E AE CTT rrr reer errr rer EE POSICOGG ieee E E E create E E A EE N COn E E E E E Contact Number or email asessssssessesssessesserssrssesserserssesserserssesserserssessersersserseesersserst LIAISON NT a A S E E E E eee Dei ates a cre ciciatecteaeterevoteins atecicies oie gn aiee aacawunle cuss neuaatsedeacsieasncmeaacenesens Page 3 of 3 Title Page LI Al SON Instrument I nitialization Procedure 1 4 Reference Revision Date Technical Note 284 Rev
4. erent situations button in the following pop up e After having pressed the boo Title LI AI SON Instrument I nitialization Procedure Reference Revision Date Technical Note 284 Rev C Attachment 1 04 08 2010 Error 9009 Break e After having pressed the button in the following window Machine is halted Cuvette Loader Washer Lift Stacker Pusher Incubator Loader Backtransport Incubator Chamber Transport Washer Loader Chamber Lift Washer Transport Pipettor Low Level Command as ip Send x Break v ontinue e After having pressed the 2 2 button Title LI Al SON Instrument I nitialization Procedure Reference Revision Technical Note 284 Rev C Attachment 1 Process Functions Low Level DF 1411 er During the initialization procedure the following pop up will appear first Device Initialization Sending Globaldata The entire procedure will finish when the last pop up appears Device Initialization Arranging Database Date 04 08 2010 Title LI Al SON Instrument I nitialization Procedure Reference Revision Date Technical Note 284 Rev C Attachment 1 04 08 2010 Device Initialization Device Initialization When the above pop up disappears from the screen initialization is completed and instrument is ready to be used
5. particle rotation is very visible and clearly audible to the User In addition a series of low RLU values and a series of unexpected patient controls and calibrators results should also be recognized by the User As a consequence of the above DiaSorin deems that there is no need to review previous results Advise on action to be taken by the user Never open either the reagent or sample flap door during the System Initialization Procedure Carefully read the Technical Note 284 including clarification on the LIAISON Analyzer initialization procedure Fill the confirmation form to be sent back to the manufacturer Page 1 of 3 DiaSorin S p A Via Crescentino snc 13040 Saluggia VC Italy oa tel 39 0161 487093 The Diagnostic Specialist ee eaa www diasorin com DiaSorin Transmission of this Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred Please transfer this notice to other organisations on which this action has an impact Contact reference person Name Antonella Fassio Organisation DiaSorin S p A Address Via Crescentino S n c 13040 Saluggia VC Italy Contact details E mail antonella fassio diasorin it Tel 39 0161 487 849 The undersigned confirms that this notice has been provided to the appropriate Regulatory Agency Signature Antonella
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