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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm May 07, 2003
Date Posted June 17, 2003
Recall Status1 Terminated 3 on May 03, 2004
Recall Number Z-0928-03
Recall Event ID 26321
Product Classification Reagent, Immunoassay, Igg - Product Code KTO
Product iVIEW DAB Detecion Kit.

Catalog Number 760-091
Code Information Lot 400566
Recalling Firm/
Ventana Medical Systems Inc
1910 E Innovation Park Dr
Tucson AZ 85737
For Additional Information Contact Sam Rua
Manufacturer Reason
for Recall
Kit does not stain tissues properly.
FDA Determined
Cause 2
Action Recall notification was made by telephone on May 6 and 7, 2003. A faxed letter and response form followed.
Quantity in Commerce 409 kits
Distribution Nationwide.
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.