Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.
FDA Recall Z-0807-05 · Posted 2005-05-10
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Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeDHN
Date Initiated2004-09-24
Date Terminated2006-07-22
Product Quantity13
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.
Firm Action
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
Root Cause
Other
Distribution Pattern
OH, NJ, KY, TX, NC, FL, VA, WA, AL, CO, MO, AZ , CA , CT & NV
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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