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 1 Device Recall VENTANA Basal Cell Cktl

  • 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 1 Device Recall VENTANA Basal Cell Cktlsee related information
Date Initiated by FirmAugust 02, 2018
Date PostedSeptember 14, 2018
Recall Status1 Terminated 3 on November 22, 2021
Recall NumberZ-3009-2018
Recall Event ID 80807
Product Classification Immunohistochemical reagent, antibody (monoclonal or polyclonal) to p63 protein in nucleus of prostatic basal - Product Code NJT
ProductVENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
Code Information Lot Number: Y20881, UDI: 4015630984534
Recalling Firm/
Manufacturer		 Ventana Medical Systems Inc
1910 E Innovation Park Dr
Oro Valley AZ 85755-1962
For Additional Information Contact
800-227-2155
Manufacturer Reason
for Recall		Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.
Quantity in Commerce75 units
Distributionworldwide
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.
-
-