Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Polymedco PolyTiter Application Software Version 2.8

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall Polymedco PolyTiter Application Software Version 2.8see related information
Date Initiated by FirmJune 30, 2004
Date PostedApril 06, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall NumberZ-0676-05
Recall Event ID 30934
510(K)NumberK822397 
Product Classification Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DHN
ProductPolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604
Code Information polyTiter software version 2.8
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		The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.
FDA Determined
Cause 2		Other
ActionAll customers were notified of the problem via phone and letter. Verbal instructions were given of how to change the Calibrator 2 titer to the correct one. A letter instructs customer to return software disc to DiaSorin, remove version 2.8 from the computer and install version 2.8.1.
Quantity in Commerce14
DistributionAL, AZ, CA, CO, FL, KY, MO, NC, NJ, NV, OH, TX, & VA
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
-
-