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U.S. Department of Health and Human Services

Class 2 Device Recall Agendia MammaPrint

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 Class 2 Recall
Agendia MammaPrint
see related information
Date Posted April 12, 2010
Recall Status1 Terminated on June 18, 2010
Recall Number Z-1321-2010
Recall Event ID 54930
Premarket Notification
510(K) Numbers
K070675  K080252  K081092 
Product Classification Classifier, Prognostic, Recurrence Risk Assessment, Rna 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, California 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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NYI and Original Applicant = AGENDIA
510(K)s with Product Code = NYI and Original Applicant = AGENDIA BV
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