Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentra

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain. Quantity: 17 units Lot/code info: UDI/DI 15099590732103, Serial Numbers: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282

UPC codes

15099590732103

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.