FDA’s MedWatch Safety Alerts for Consumers: April 2015

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Problems with Mammograms at Coastal Diagnostic Center, California

FDA is alerting patients about possible problems with the quality of mammograms taken any time on or after February 24, 2013, at Coastal Diagnostic Center in Pismo Beach, California. The American College of Radiology revoked the facility’s accreditation effective April 10, 2015.

Risk: This does not necessarily mean that the results of the mammograms were inaccurate. But patients should consider having their mammograms reevaluated at a facility certified by the Mammography Quality Standards Act (MQSA) to determine whether they need a repeat mammogram or additional medical follow-up.

Recommendations:

FDA has some recommendations for patients who had a mammogram at Coastal Diagnostic Center any time on or after February 24, 2013.

If you have had a more recent mammogram at a MQSA-certified facility since February 24, 2013, follow the recommendations from that facility.

If you have not had a new mammogram at a MQSA-certified facility since then, follow these guidelines:

Talk with your health care provider as soon as possible about the need for a follow-up exam.
If your health care provider recommends a repeat mammogram, it should be done at a MQSA-certified facility to ensure quality and accuracy. Find a MQSA-certified facility in your area online or by calling the National Cancer Institute at 1-800-422-6237.
If you need a repeat mammogram and your health insurance will not pay for it, call the National Cancer Institute at 1-800-422-6237 for a listing of MQSA-certified facilities near you that will provide free or low-cost mammograms.

For more information:

04/30/2015 - FDA Safety Communication

Illegal Ebola Virus Test Kits by LuSys Laboratories

FDA has not cleared or approved the Ebola Virus One-Step Test Kits for use or sale. The results obtained from these test kits have not been demonstrated to be accurate and should not be used as tests for Ebola infection.

Risk: False test results may be life-threatening and may put consumers and others at risk of getting Ebola.

Recommendations:

Customers should stop using the test kits and return them to LuSys Laboratories.

Report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

For more information:

04/23/2015 - FDA Recall Notice

June 25, 2015