Diasorin Inc. Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
all versions of software
Products Sold
all versions of software
Diasorin Inc. is recalling Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and u due to A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CO, CT, FL, KY, MO, NV, NJ, NC, OH, TX, VA, WA
Page updated: Jan 10, 2026