Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
This recall has been completed (originally issued February 6, 2025).
- Company
- Beckman Coulter, Inc.
- Recall Initiated
- January 3, 2024
- Posted
- February 6, 2025
- Recall Number
- Z-1115-2025
- Quantity
- 61 units
- Firm Location
- Chaska, MN
- Official Source
- View on FDA website ↗
Reason for Recall
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland.
Lot / Code Info
UDI/DI 15099590732103, serial numbers: 300208, 300201, 300184, 300185, 300169, 300225, 300175, 300172, 300221, 300209, 300211, 300212, 300213, 300214, 300215, 300210, 300174, 300226, 300204, 300216, 300217, 300170, 300220, 300176, 300188, 300199, 300200, 300177, 300222, 300224, 300173, 300181, 300202, 300191, 300223, 300171, 300186, 300190, 300203, 300178, 300195, 300189, 300198, 300227, 300228, 300168, 300194, 300205, 300206, 300207, 300197, 300218, 300179, 300182, 300192, 300219, 300193, 300183, 300180, 300187, 300196.
Root Cause
Software design
Action Taken
A field service engineer was dispatched to the customer site to perform the software update and to replace the PCB TSI-RSI board from 01/03/2024 through 12/26/2024.