Diagnostic Equipment

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.