| Class 3 Device Recall LIAISON 25OH Vitamin D Kit | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MRG
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