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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
FEI Number 2182595
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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