Z-1321-2010

Agendia MammaPrint, Catalog Numbers MP01, MP US version 03

Name: Z-1321-2010 Agendia MammaPrint, Catalog Numbers MP01, MP US version 03
Creator: Agendia Inc
Published: 2010-03-03
License: https://open.fda.gov/license/

Agendia Inc / initiated 2010-03-03 / Terminated

FDA source

Agendia Inc began a recall of Agendia MammaPrint, Catalog Numbers MP01, MP US version 03 on 2010-03-03. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1321-2010
Status: Terminated
Initiated: 2010-03-03
Posted: 2010-04-12
Terminated: 2010-06-18
Recalling firm: Agendia Inc
Product: Agendia MammaPrint, Catalog Numbers MP01, MP US version 03
Product code: NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
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 root 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.
Product codes and lots: MP US version 03

Product code NYI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)