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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Potential breach in the sterility barrier for tray ring covers.
Due to microbial growth causing interference with interpretation.
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
There is a potential for foreign matter.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
Products in this lot may have compromised barrier seals, introducing a risk to sterility.