FDA Medical devices recall ·
Beckman Coulter DxI 9000 Access Immunoassay Analyzer recall
- Recall number
- Z-1664-2025
- Date
- (initiated March 27, 2025)
- Company / brand
- Beckman Coulter, Inc.
1000 Lake Hazeltine Dr, Chaska, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 370 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1664-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.