Becton Dickinson & Co.: BD Synapsys Informatics Solution, Catalog Number 444150

Hazard

There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.

Details from the source

Reason for recall: There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly. Distribution: US States: CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI. Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom Quantity: 102 systems Lot/code info: UDI-DI: 00382904441500;

UPC codes

00382904441500

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.