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U.S. Department of Health and Human Services

Class 1 Device Recall OptiView DAB IHC Detection Kit

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  Class 1 Device Recall OptiView DAB IHC Detection Kit see related information
Date Initiated by Firm August 02, 2018
Date Posted September 14, 2018
Recall Status1 Terminated 3 on November 22, 2021
Recall Number Z-2996-2018
Recall Event ID 80807
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700
Immunohistochemistry (IHC) for in vitro diagnostic use.
Code Information Lot Numbers: Y25760, E00119, Y24225, UDI: 4015630984039
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
Action The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.
Quantity in Commerce 11,712 units
Distribution worldwide
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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