Agendia MammaPrint, Catalog Numbers MP01, MP US version 03
FDA device recall Z-1321-2010 · posted 2010-04-12 · Terminated
Recall details
- Recalling firm
- Agendia Inc
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NYI
- Quantity affected
- 107
- Distribution
- Nationwide.
- Date initiated
- 2010-03-03
- Date posted
- 2010-04-12
- Date terminated
- 2010-06-18
- Location
- Huntington Beach, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO MAMMAPRINT (K081092) | Agendia | 2009-12-11 |
| MODIFICATION TO MAMMAPRINT (K080252) | Agendia BV | 2008-07-21 |
| MAMMAPRINT (K070675) | Agendia BV | 2007-06-22 |