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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm April 04, 2003
Date Posted November 19, 2003
Recall Status1 Terminated 3 on March 30, 2004
Recall Number Z-0115-04
Recall Event ID 26070
Product Classification Immunohistochemistry Antibody Assay, C-Kit - Product Code NKF
Product CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939
Code Information Lot Numbers; 23095A, 23340A, and 30116A.
Recalling Firm/
Manufacturer		 Ventana Medical Systems Inc
1910 E Innovation Park Dr
Tucson AZ 85737
Manufacturer Reason
for Recall		 Increased level of non-specific or background staining.
FDA Determined
Cause 2		 Other
Action Customers were sent notice via letter on 4/4/2003. Confirmation of delivery has been obtained for all customers. Product recovery is underway.
Quantity in Commerce 95
Distribution Nationwide and to Japan, France and Puerto Rico.
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.
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