Sharesource Connectivity Platform for Use with Homechoice Claria recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, Korea, New Zealand, Taiwan, Thailand, France, Germany, Ireland, Netherlands, Italy, Spain, Turkey, United Kingdom, Chile, and Colombia.

Nationwide