Hologic, Inc. - 698214 - 12/18/2024 | FDA
5 days ago · WARNING LETTER CMS # 698214. December 18, 2024. Dear Mr. MacMillan: During an inspection of your firm located in Marlborough, MA on July 30, 2024, through September 24, 2024, an investigator from ...
Hologic receives FDA warning letter over Biozorb implantable …
3 days ago · The warning letter follows an FDA inspection of Hologic’s Marlborough, Massachusetts, headquarters between July 30, 2024, and Sept. 24, 2024. The FDA raised concerns that Biozorb’s device design did not address the intended patient population and anatomy types, as well as surgical requirements such …
FDA threatens Hologic with punishment for reported errors in …
3 days ago · The U.S. Food and Drug Administration is threatening radiology vendor Hologic Inc. with possible punishment after reported errors in the manufacturing of a troubled device. Authorities communicated their concerns in a December warning letter to the Marlborough, Massachusetts company, posted online Tuesday. They’re troubled by Hologic’s ...
FDA warns Hologic to do more to prevent harm from component …
1 day ago · The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company Hologic Inc. over concerns it hasn't done enough to prevent harm from a ...
Hologic warned over recalled BioZorb implants | RAPS
5 days ago · Despite pulling its BioZorb implantable radiographic markers off the market following hundreds of complaints and dozens of reported injuries, the US Food and Drug Administration (FDA) sent a warning letter to Hologic last month raising issues with its design controls and corrective and preventive action (CAPA) procedures.
FDA Warns Hologic Over BioZorb Manufacturing Violations
1 day ago · The Food and Drug Administration issued a warning letter to Hologic Inc. HOLX, citing violations in the manufacturing and reporting processes for its BioZorb product line.. The letter, addressed ...
Hologic receives warning letter over implantable devices
3 days ago · Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line following the company's recall of the devices toward the end of last year.. The ...
Recall: Hologic Removes BioZorb for Patient Complication Risks
Dec 18, 2024 · On October 24, 2024, Hologic sent all affected customers an Urgent Medical Device Recall letter recommending the following actions: Be aware that there is no need to have the BioZorb Marker...
Class 1 Device Recall BioZorb LP Marker - Food and Drug Administration
Mar 13, 2024 · " Report any problems or complications experienced by patients following placement of the BioZorb Marker devices to Hologic. Complaints can be submitted to [email protected]...
Hologic breast care devices could cause life-threatening …
Feb 28, 2024 · Certain Hologic breast care devices could cause serious complications, according to a warning from the U.S. Food and Drug Administration issued Tuesday. The alert pertains to the BioZorb and BioZorb LP markers, implanted in soft tissue to indicate the site for radiation therapy or other medical procedures.
- Some results have been removed