Device product
BD Synapsys Informatics Solution, Catalog Number 444150
Z-2099-2023
Product summary
- Event
- Event 92406
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 102 systems
- Official record key
device-enforcement:Z-2099-2023
Official wording
Reason: 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.
Code information: UDI-DI: 00382904441500;
Distribution pattern: 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
Derived failure modes
-
Unknown
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.