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U.S. Department of Health and Human Services

Class 3 Device Recall LIAISON 25OH Vitamin D Kit

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  Class 3 Device Recall LIAISON 25OH Vitamin D Kit see related information
Date Initiated by Firm February 01, 2008
Date Posted May 07, 2008
Recall Status1 Terminated 3 on October 31, 2008
Recall Number Z-1240-2008
Recall Event ID 46832
510(K)Number K032844  
Product Classification Vitamin D test systems - Product Code MRG
Product LIAISON¿ 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082
Code Information Lot Numbers: 120422 and 120423.
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
P.O Box 285
Stillwater MN 55082-0285
For Additional Information Contact
651-439-9710
Manufacturer Reason
for Recall		 Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified by a Diasorn Customer Notification Letter sent by email on 2/1/08. The letter instructs users to stop using the affected kits, destroy any kits remaining in inventory and to return a response form in order to receive replacement product. For additional information contact 1-800-328-1482.
Quantity in Commerce 2,267 kits
Distribution Worldwide Distribution including USA states of AR, CA, GA, IA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OR, PA, TN, UT and WA and country of Austria.
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 = DIASORIN, INC.
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