FDAFDA · Food and drugs·Recall number Z-1546-2024
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.
Published September 11, 2024 · Recall initiated: March 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Beckman Coulter, Inc.
- Distributor
- Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.
- Lot
- UDI/DI 15099590732103, Serial Numbers: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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