Hologic received a warning letter in December from the Food and Drug Administration related to safety concerns with the company’s Biozorb implantable radiographic markers. The FDA found that ...
Design and manufacturing flaws in BioZorb devices, inadequate quality controls, and delayed responses to safety complaints. Calls for a comprehensive corrective plan within 15 business days to ...
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Hologic recalls BioZorb Marker over safety concernsThe BioZorb Marker is an implantable radiographic marker used to mark soft tissues, such as breast tissue, for future medical procedures, according to the FDA. More on Hologic Hologic, Inc. (HOLX ...
Marlborough-based medical device manufacturer Hologic has been issued a warning letter from the U.S. Food and Drug Administration concerning its BioZorb Marker, a device originally recalled in March.
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