Z-1664-2025 Class II Ongoing
FDA device recall Z-1664-2025 was initiated by Beckman Coulter, Inc. on March 27, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 370 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 30, 2025
- Initiation Date
- March 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 370 units
Product Description
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
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 Pattern
Worldwide distribution.
Code Information
UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below