Recall archive / FDA device enforcement
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument — FDA record Z-1115-2025
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 3, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
- Reason
- A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 61 units
- Agency-reported status
- Completed
- Source record identifier
- Z-1115-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 12, 2025
- Recall initiation date
- Jan 3, 2024
- Center classification date
- Feb 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.