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Recall Observatory FDA recall evidence

Device product

BD Synapsys Informatics Solution, Catalog Number 444150

Z-2099-2023

June 08, 2023

Class II

Product summary

Firm
Becton Dickinson & Co.
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

    reason.no_named_rule · v1.0.0

    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.