Recall Z-2099-2023— Becton Dickinson & Co.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2023-06-08. FDA's recall record names no specific 510(k) clearance for this event. Product: BD Synapsys Informatics Solution, Catalog Number 444150. 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..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-08
- Firm location
- Sparks, MD, United States
Product description
BD Synapsys Informatics Solution, Catalog Number 444150
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.