Beckman Coulter DxI 9000 Access Immunoassay Analyzer
This recall is currently active, issued April 24, 2025. It was issued by Beckman Coulter, Inc..
- Company
- Beckman Coulter, Inc.
- Recall Initiated
- March 27, 2025
- Posted
- April 24, 2025
- Recall Number
- Z-1664-2025
- Quantity
- 370 units
- Firm Location
- Chaska, MN
- Official Source
- View on FDA website ↗
Reason for Recall
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
Distribution
Worldwide distribution.
Lot / Code Info
UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below
Root Cause
Software design
Action Taken
Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/27/2025 via USPS first class mail. The notice explained the issue with the device, impact to the patient, and provided a workaround until a software upgrade is available. If the consignee further distributed the affected device, they were directed to provide a copy of the notice to the recipient. For questions, contact Customer Support Center, from the website: http://www.beckmancoulter.com