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U.S. Department of Health and Human Services

Class 3 Device Recall Software specific to microtiter plate instrument for use with Diastat AntiBeta2 Glycoprotein kit

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  Class 3 Device Recall Software specific to microtiter plate instrument for use with Diastat AntiBeta2 Glycoprotein kit see related information
Date Initiated by Firm October 26, 2004
Date Posted April 06, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-0674-05
Recall Event ID 30924
510(K)Number K982879  
Product Classification System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) - Product Code MSV
Product Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit.
Code Information software version 12
Recalling Firm/
Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact DiaSorin Technical Services
800-328 Ext. 1482
Manufacturer Reason
for Recall
Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.
FDA Determined
Cause 2
Action Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert specifications.
Quantity in Commerce 7
Distribution CT, MI, MT, UT & CANADA
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MSV and Original Applicant = SHIELD DIAGNOSTICS, LTD.