The FDA has issued a safety notification alerting patients and providers about problems associated with the quality of mammograms performed at Huntington Radiology in Huntington Park, Calif.
The notification warned that patients who had mammograms performed at the facility between Sept. 9, 2008 and Sept. 9, 2010 that a review of a sample of mammograms acquired at the facility during the two-year period indicated poor quality mammograms with possibly unreliable results.
According to the FDA, Huntington Radiology did not meet the quality standards required by the Mammography Quality Standards Act (MQSA) of 1992. The American College of Radiology had revoked its accreditation and the facility has not performed mammography as of Sept. 9, 2010.
Huntington Radiology sent letters to patients and their referring healthcare providers, but has not been able to demonstrate to the FDA’s satisfaction that all affected patients were successfully notified.
The FDA stressed that the alert means patients need to have their mammograms re-evaluated and possibly repeated, but it does not mean results of all studies were inaccurate.