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U.S. Department of Health and Human Services

Class 3 Device Recall Diastat Software for use with Diastat AntiMitochondrial Antibody Kit

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 Class 3 Device Recall Diastat Software for use with Diastat AntiMitochondrial Antibody Kitsee related information
Date Initiated by FirmApril 12, 2004
Date PostedApril 06, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall NumberZ-0673-05
Recall Event ID 30922
510(K)NumberK921183 
Product Classification Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DBM
ProductData reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit
Code Information Software version 12
FEI Number 2182595
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information ContactDiaSorin Technical Service
800-328-1482
Manufacturer Reason
for Recall		The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
FDA Determined
Cause 2		Other
ActionA notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed.
Quantity in Commerce8
DistributionCA, CT, KS, MA & WA
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 = DBM
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