Z-2099-2023 Class II Ongoing
FDA device recall Z-2099-2023 was initiated by Becton Dickinson & Co. on June 8, 2023 and is designated Class II. 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 actio… The recall status is ongoing. Affected quantity: 102 systems.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2023
- Initiation Date
- June 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102 systems
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.
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
Code Information
UDI-DI: 00382904441500;