Recall archive / FDA device enforcement
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitativ... — FDA record Z-1546-2024
Reported ongoing
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 Mar 5, 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
- DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
- Reason
- Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 17 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1546-2024
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: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.
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
- Sep 11, 2024
- Recall initiation date
- Mar 5, 2024
- Center classification date
- Aug 30, 2024
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.