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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin programming software

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 Class 3 Device Recall DiaSorin programming softwaresee related information
Date Initiated by FirmApril 12, 2004
Date PostedApril 06, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall NumberZ-0675-05
Recall Event ID 30928
510(K)NumberK952183 
Product Classification System, Test, Thyroid Autoantibody - Product Code JZO
ProductData reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700).
Code Information software version 9 thru 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 reader (Bio-Tek ELx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.
FDA Determined
Cause 2		Other
ActionCustomers were sent a notification letter directing customers to check historical data for negative control results reading greater than 0.95 but less than 1.0. These results are invalid and patient results should not have been reported. Customers are instructed to verify negative control manually until new software version is installed. An effectiveness check form is requested to be returned.
Quantity in Commerce6
DistributionCA, FL, MA, NY & TX
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 = JZO
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