Class 2 Device Recall Agendia MammaPrint

• Date Initiated by Firm: March 03, 2010
• Date Posted: April 12, 2010
• Recall Status: Terminated on June 18, 2010
• Recall Number: Z-1321-2010
• Recall Event ID: 54930
• 510(K)Number: K070675 K080252 K081092
• Product Classification: Classifier, prognostic, recurrence risk assessment, RNA a gene expression, breast cancer - Product Code NYI
• Product: Agendia MammaPrint, Catalog Numbers MP01, MP US version 03
• Code Information: MP US version 03
• Recalling Firm/ Manufacturer: Agendia Inc; 17742 Beach Blvd Ste 250; Huntington Beach CA 92647-6835
• For Additional Information Contact: Miriam Reyes; 714-849-7515 Ext. 234
• Manufacturer Reason for Recall: Over a period of about 6 months in about 15% of results provided Agendia has been "over reporting" the chance of metastasis risk being 29% risk of recurrence instead of 10% risk. This over reporting of risk did not cause direct injury to patients. However, if used by physicians as the sole basis for decision-making, affected patients may have received unnecessary therapy.
• FDA Determined Cause: Other
• Action: Communication with physicians was initiated by the firm's Chief Medical Officer on March 3, 2010. The firm's representatives will meet with treating physicians in person while having the corrected results in hand to inform each in person of the action, to allow a decision of the best course of action. Physicians will be provided with background information on the issue at hand and corrected results. As follow up, the physician would receive a corrected report per patient by FedEx in order to register the reception of corrected information. Because each user received a personal visit, no other contact information was planned or provided by Agendia.
• Quantity in Commerce: 107
• 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.

• 510(K) Database: 510(K)s with Product Code = NYI; 510(K)s with Product Code = NYI