Recalls and Safety Alerts:
Problem with Quality of Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication
The FDA is alerting patients who had mammograms at Coastal Diagnostic Center located in Pismo Beach, California anytime on or after February 24, 2013, about possible problems with the quality of their mammograms. This does not mean that the results of the mammograms were inaccurate, but patients should consider having their mammograms re-evaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if there is a need to repeat the mammogram or have additional medical follow-up…
Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall
The 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 in vitro diagnostic tests for Ebola infection…
VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall
OriGen Biomedical initiated a nationwide recall for one lot (lot N18549, expiration 09/2018) of 51 VV13F Reinforced Dual Lumen ECMO Catheters. Affected devices have been found to have the potential for a separation of the clear extension tube from the hub in which it is inserted, which potentially could result in required intervention to prevent permanent impairment/damage…
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