Date Initiated by Firm | February 14, 2005 |
Date Posted | March 18, 2005 |
Recall Status1 |
Terminated 3 on July 22, 2006 |
Recall Number | Z-0637-05 |
Recall Event ID |
31167 |
510(K)Number | K032844 |
Product Classification |
System, Test, Vitamin D - Product Code MRG
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Product | LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E. |
Code Information |
catalog no. 310900, lot 114439E |
Recalling Firm/ Manufacturer |
Diasorin Inc. 1951 Northwestern Ave S Stillwater MN 55082-7536
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For Additional Information Contact | DiaSorin Technical Service 800-328-1482 |
Manufacturer Reason for Recall | Results of an internal inspection show Lot 114439E to have calibrator 1 and Calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values. |
FDA Determined Cause 2 | Other |
Action | DiaSorin Customer Notification dated 02/14/05 was sent to customers instructing them to destroy all kits from the affected lot number. Customers were also asked to complete and return a form indicating how many kits were destroyed. |
Quantity in Commerce | 131 |
Distribution | MI, NJ, Germany, Spain and Belgium |
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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