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/ Manufacturer |
Ventana Medical Systems Inc 1910 E Innovation Park Dr Tucson AZ 85737
|
For Additional Information Contact |
Sam Rua 520-229-3911
|
Manufacturer Reason for Recall |
Kit does not stain tissues properly.
|
FDA Determined Cause 2 |
Other |
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
|
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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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