Date Initiated by Firm |
August 02, 2018 |
Date Posted |
September 14, 2018 |
Recall Status1 |
Terminated 3 on November 22, 2021 |
Recall Number |
Z-3006-2018 |
Recall Event ID |
80807 |
510(K)Number |
K103818
|
Product Classification |
Immunohistochemistry assay, antibody, progesterone receptor - Product Code MXZ
|
Product |
CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use. |
Code Information |
Lot Numbers: Y12992, Y18852, Y23051, UDI: 4015630972203 |
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 |
1655 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.
|
510(K) Database |
510(K)s with Product Code = MXZ and Original Applicant = VENTANA MEDICAL SYTEMS, INC
|