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U.S. Department of Health and Human Services

Class 3 Device Recall Programming software for Polymedco PolyTiter Immunofluorescent Titration System

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 Class 3 Device Recall Programming software for Polymedco PolyTiter Immunofluorescent Titration Systemsee related information
Date Initiated by FirmSeptember 24, 2004
Date PostedMay 10, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall NumberZ-0807-05
Recall Event ID 30946
510(K)NumberK822397 
Product Classification Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DHN
ProductProgramming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.
Code Information all versions of software
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information ContactDiaSorin Technical Services
800-328-1482
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionCustomers 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
Quantity in Commerce13
DistributionOH, NJ, KY, TX, NC, FL, VA, WA, AL, CO, MO, AZ , CA , CT & NV
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DHN
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