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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin

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  Class 3 Device Recall DiaSorin see related information
Date Initiated by Firm August 21, 2007
Date Posted September 20, 2007
Recall Status1 Terminated 3 on October 17, 2008
Recall Number Z-1237-2007
Recall Event ID 39413
510(K)Number K953567  
Product Classification in vitro diagnostic - Product Code MRG
Product 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.
Code Information Part # 68100E, lot # 119604A
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
P.O Box 285
Stillwater MN 55082-7536
For Additional Information Contact
651-439-9710
Manufacturer Reason
for Recall		 25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.
FDA Determined
Cause 2		 Other
Action Consignees were notified by phone on 8/21/07 followed by a written notification by Fax or email. The letter described the product and problem and recommended to inspect the kits and to destroy all tracer vials of lot number 726023. They also requested the consignee to return the findings by fax or mail.
Quantity in Commerce 117 kits
Distribution Worldwide, including USA, CANADA, BRAZIL, INDIA, QATAR, SWEDEN, URUGUAY, ARGENTINA, and JORDAN.
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 = MRG and Original Applicant = INCSTAR CORP.
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