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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin 25Hydroxyvitamin D 125I RIA Kit.

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 Class 3 Device Recall DiaSorin 25Hydroxyvitamin D 125I RIA Kit.see related information
Date Initiated by FirmJune 30, 2004
Date PostedApril 13, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall NumberZ-0705-05
Recall Event ID 30936
510(K)NumberK983617 
Product Classification Automated Radioimmunoassay Systems, For Clinical Use - Product Code LCI
ProductDiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A., Lot # 113300B.
Code Information Ref No. 68100E, Lot # 113300B.
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		An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18.
FDA Determined
Cause 2		Other
ActionA customer notification letter was sent to customers 6/30/04. The letter identified theproduct, problem and the correct expiration date. Customers were instructed to complete the response form on the lower portion of the notification and fax it back to DiaSorin.
Quantity in Commerce181
DistributionMI, IL, AZ, MN, OR, GA, MO, Sweden, Germany, Great Britain, Spain, Belgium, Italy, Norway, Brazil, Hungary, Switzerland
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 = LCI
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