| Class 3 Device Recall Programming software for Polymedco PolyTiter Immunofluorescent Titration System | |
Date Initiated by Firm | September 24, 2004 |
Date Posted | May 10, 2005 |
Recall Status1 |
Terminated 3 on July 22, 2006 |
Recall Number | Z-0807-05 |
Recall Event ID |
30946 |
510(K)Number | K822397 |
Product Classification |
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DHN
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Product | Programming 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
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For Additional Information Contact | DiaSorin 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 |
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 |
Quantity in Commerce | 13 |
Distribution | OH, NJ, KY, TX, NC, FL, VA, WA, AL, CO, MO, AZ , CA , CT & NV |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DHN
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