Beckman coulter chemistry analyzer
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Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. With random access throughput of up to 400 photometric tests per hour (up to 800 with electrolytes. The AU480 is ideal as a primary chemistry analyzer for small- to medium-sized hospitals and laboratories, or as a dedicated specialty chemical or STAT analyzer for larger institutions. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Beckman Coulter AU480 Chemistry Analyzer Au480 Test Menu Pdf. Worldwide Distribution - US (nationwide (including Guam and Puerto Rico), and Internationally to Albania, Algeria, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Liberia, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States Uruguay, Viet Nam, Zambia, Zimbabwe.ġ A record in this database is created when a firm initiates a correction or removal action.
#Beckman coulter chemistry analyzer crack
Thus, there are no specific actions the customer could take to inspect, identify, or mitigate the potential for a crack or leakage of the C cup.įor questions regarding this recall call 71. BEC did not issue a customer notification letter, as we do not believe that a notificationletter was either warranted or of any potential use or value to our customers, because the coolant cup (͌ cup) is an internal component that only a BEC Field Service Engineer (FSE) can access and inspect i.e., the C cup is not in a customer-accessible part of theĪnalyzer. Home / Evaluation of Sentinel Pancreatic Amylase assay on Beckman Coulter AU5800 clinical chemistry analyzer. In March 2011, the material and molding process of the Coolant cup (C cup) was changed. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.
#Beckman coulter chemistry analyzer cracked
The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.īeckman coulter has received complaints regarding leaking and cracked C cups.
#Beckman coulter chemistry analyzer license
Nothing contained herein shall be construed as granting by implication, estoppel or otherwise any license or right under any patent or trademark of Beckman Coulter or any third party.Class 2 Device Recall Beckman Coulter AU480 Chemistry AnalyzerĪnalyzer, chemistry (photometric, discrete), for clinical use - Product Code JJEĪU480 Chemistry Analyzers, Reference No. Except as expressly provided above, nothing contained herein shall be construed as granting any license or right under any Beckman Coulter copyright. Government Users Restricted Rights - As per GSA ADP Schedule Contract with Beckman Coulter, Inc., the use, duplication or disclosure is restricted as follows: Beckman Coulter hereby authorizes user to copy those documents published on the World Wide Web by Beckman Coulter, for noncommercial use, and only within the user's organization.
#Beckman coulter chemistry analyzer download
View & download of more than 71 Beckman coulter PDF. Automate and consolidate chemistry testing with ClearChem 125 test menu. All other trademarks are the property of their respective owners. The Beckman Coulter AU480 is ideal as a primary chemistry analyzer for small- to medium-size hospitals and laboratories or as a dedicated specialty analyzer for larger institutions. in the United States and other countries. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc.