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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 kitsee related information
Date Initiated by FirmOctober 26, 2004
Date PostedApril 06, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall NumberZ-0674-05
Recall Event ID 30924
510(K)NumberK982879 
Product Classification System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) - Product Code MSV
ProductData 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/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information ContactDiaSorin 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		Other
ActionCustomers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert specifications.
Quantity in Commerce7
DistributionCT, MI, MT, UT & CANADA
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 = MSV
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