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U.S. Department of Health and Human Services

Class 3 Device Recall BINDAZYME

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  Class 3 Device Recall BINDAZYME see related information
Date Initiated by Firm October 28, 2009
Date Posted June 30, 2010
Recall Status1 Terminated 3 on June 30, 2010
Recall Number Z-1942-2010
Recall Event ID 55801
510(K)Number K031563  
Product Classification in vitro diagnostic - Product Code DAK
Product Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
Code Information Lot numbers: 273005A, 273005B, 273005C, and 273005D
Recalling Firm/
Manufacturer		 Inova Diagnostics Incorporated
9900 Old Grove Rd
San Diego CA 92131-1638
For Additional Information Contact
858-586-9900
Manufacturer Reason
for Recall		 The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as "tissue Transglutaminase Coated Wells" instead of "C1q Coated Wells".
FDA Determined
Cause 2		 Process control
Action Notification letters from INOVA Diagnostics Incorporated were mailed to each of the consignees via Certified mail on October 30, 2009. The notification letters inform the consignees of the reason for recall and provided instructions for final disposition of the recalled kits. In addition, a FAX back Attachment was attached to the recall notice for customers to respond to the recall.
Quantity in Commerce 700 kits
Distribution Worldwide distribution: USA, Germany, Italy, Belgium, Romania, Portugal, Argentina, Spain, Sweden, 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 = DAK and Original Applicant = THE BINDING SITE, LTD.
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