BD Synapsys Informatics Solution, Catalog Number 444150
Reported: July 12, 2023 Initiated: June 8, 2023 #Z-2099-2023
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.
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 102 systems
- 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
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
BD Synapsys Informatics Solution, Catalog Number 444150. Recalled by Becton Dickinson & Co.. Units affected: 102 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2023. Severity: Moderate. Recall number: Z-2099-2023.
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