Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 409–420 of 1,125 recalls
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, du…
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, du…
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, du…
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, du…
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, du…
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor.…
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formu…
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.