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U.S. Department of Health and Human Services

Class 2 Device Recall Calcitonin ELISA Kit

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  Class 2 Device Recall Calcitonin ELISA Kit see related information
Date Initiated by Firm September 18, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on March 28, 2015
Recall Number Z-0467-2015
Recall Event ID 69621
510(K)Number K982491  
Product Classification Radioimmunoassay, calcitonin - Product Code JKR
Product Calcitonin ELISA Kit, Code No. 7024, 7024BU.

Intended use of this product is the quantitative determination of Calcitonin in human serum.
Code Information Lot No. 2041, 2071, 2089, 2124, 2167, 2178, 2180.
Recalling Firm/
17571 Von Karman Ave
Irvine CA 92614-6207
For Additional Information Contact
Manufacturer Reason
for Recall
A potential issue with false high values.
FDA Determined
Cause 2
Material/Component Contamination
Action An Urgent Field Safety Notice dated 9/18/14 was sent to all their customers who purchased the Calcitonin ELISA Kit. The letter informed the customers of the problems identified and the actions to be taken. Customers were to examine their inventory immediately and quarantine any affected product. Also, customers were asked to notify any customers that the product was further distributed to. Customers with questions were instructed to contact their local Customer Service or Sales Representative regarding the recall notification. Customers were instructed to complete and return the enclosed response form by either fax or email as soon as possible and not later than 10/1/14.
Quantity in Commerce 1,062 units
Distribution Worldwide Distribution -- USA, including the states of NH, CA, NJ, FL; and, the countries of Russia, Ukraine, Switzerland, Spain, Italy, Serbia, China, France, Pakistan, Austria, United Kingdom, Egypt, and India.
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 = JKR and Original Applicant = SANGUI BIOTECH, INC.