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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 29, 2005
Date Posted November 01, 2005
Recall Status1 Terminated 3 on January 29, 2007
Recall Number Z-0113-06
Recall Event ID 33707
PMA Number P980018 
Product Classification System, Test, Her-2/Neu, Ihc - Product Code MVC
Product K 520411-2, Hercep Test, 35Test, HER2, Protein
Code Information Lot number: 00016943
Recalling Firm/
Manufacturer		 Dakocytomation California Inc
6392 Via Real
Carpinteria CA 93013-2921
For Additional Information Contact Scot D. Kinghorn
805-566-5478
Manufacturer Reason
for Recall		 Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test kits. The error was in the concentration of Polyethylene Glycol contained in the formulation.
FDA Determined
Cause 2		 Other
Action Notification letter dated Sept 29,2005 was sent by certified mail to consignees instructing disposal of product.
Quantity in Commerce 545
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.
PMA Database PMAs with Product Code = MVC and Original Applicant = Agilent Technologies Singapore (International) Pte Ltd.
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