Recall Z-1115-2025
Beckman Coulter, Inc. · initiated January 3, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Codes / lots: 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.
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.
FDA-determined 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.
Details
- Recall number
- Z-1115-2025
- Initiated
- January 3, 2024
- Posted by FDA
- February 6, 2025
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 61 units
- 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.
- Recalling firm
- Beckman Coulter, Inc., Chaska, MN