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
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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
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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 |
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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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PMA Database | PMAs with Product Code = MVC
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