Becton Dickinson & Co.: Medical Device Recall in 2023 - (Recall #: Z-2099-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

BD Synapsys Informatics Solution, Catalog Number 444150

Product Classification:

Class II

Date Initiated: June 8, 2023

Date Posted: July 12, 2023

Recall Number: Z-2099-2023

Event ID: 92406

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.

Status: Ongoing

Product Quantity: 102 systems

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

Voluntary or Mandated:

Voluntary: Firm initiated