Diagnostic Equipment

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.

Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.

The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped when they reach the end of the outer lane which could result in Delay in providing patient with appropriate medical treatment. New sample needs to be drawn. Substantial discharge of biohazards material - Infection with a human transmissible blood-borne or animal pathogen which could result in Infection with a human transmissible blood-borne pathogen (e.g. infectious HBV, HCV, HIV).

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

There is potential for packaging defects that may impact the sterile barrier.

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

Incorrect version of labels were used.

There is potential for packaging defects that may impact the sterile barrier.

Incorrect version of labels were used.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).