Date Initiated by Firm | August 02, 2018 |
Date Posted | September 14, 2018 |
Recall Status1 |
Terminated 3 on November 22, 2021 |
Recall Number | Z-3003-2018 |
Recall Event ID |
80807 |
Product Classification |
Immunohistochemistry reagents and kits - Product Code NJT
|
Product | ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135
Immunohistochemistry (IHC) for in vitro diagnostic use. |
Code Information |
Lot Number: Y21610, UDI: 4015630971572 |
Recalling Firm/ Manufacturer |
Ventana Medical Systems Inc 1910 E Innovation Park Dr Oro Valley AZ 85755-1962
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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 | 354 units |
Distribution | worldwide |
Total Product Life Cycle | TPLC Device Report |
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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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