Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recallsee related information
Date Initiated by FirmApril 04, 2003
Date PostedNovember 19, 2003
Recall Status1 Terminated 3 on March 30, 2004
Recall NumberZ-0115-04
Recall Event ID 26070
Product Classification Immunohistochemistry Antibody Assay, C-Kit - Product Code NKF
ProductCONFIRM 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
ActionCustomers were sent notice via letter on 4/4/2003. Confirmation of delivery has been obtained for all customers. Product recovery is underway.
Quantity in Commerce95
DistributionNationwide and to Japan, France and Puerto Rico.
Total Product Life CycleTPLC 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.
-
-