RecallDepth

Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.

Company
Diasorin Inc.
Recall Initiated
September 24, 2004
Posted
May 10, 2005
Terminated
July 22, 2006
Recall Number
Z-0807-05
Quantity
13
Firm Location
Stillwater, MN

Reason for Recall

A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the 'refresh button' has not been pressed. The graph may appear valid; however erroneous results may occur.

Distribution

OH, NJ, KY, TX, NC, FL, VA, WA, AL, CO, MO, AZ , CA , CT & NV

Lot / Code Info

all versions of software

Root Cause

Other

Action Taken

Customers were sent a Technical Bulletin describing the correct procedure to be used when entering data into the Poly/Titer tiration system, until the updated software is installed

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