The U.S. Food and Drug Administration (FDA) has issued a warning to patients regarding mammograms performed at Advanced Women Imaging in Guttenberg, NJ, on or after March 11, 2020.
The FDA warns that the quality of the mammograms may not be up to par, and it is recommending that women ask for their mammogram and medical reports and have them reviewed at another Mammography Quality Standards Act (MQSA)-certified facility.
The facility's annual MQSA inspection showed that required quality-control tests were not performed between March 11 and August 25, 2020. The American College of Radiology (ACR) requested clinical images and documentation for an additional mammography review; the facility did not comply with this request and on September 12, its accreditation expired.
On September 15, the FDA notified Advanced Women Imaging that it must cease performing mammography.
