AR: Beckman Coulter is alerting clinical laboratories about the importance of following twice-a-week maintenance procedures for the company's UniCel DxC clinical chemistry analyzers.
MB: The company has received reports of erroneous sodium results from these analyzers, which may have led some patients to be hospitalized. In a January letter, Beckman Coulter said these errors may have been caused by excessive build-up of protein, bacteria and sample tube additives in the analyzer's ion-selective electrode flow cells.
AR: In 2008, the company had provided laboratories with an optional twice-a-week maintenance procedure to help prevent build-up on the instrument. The company's letter says that because of the risks to health, it's now mandatory that laboratories perform this maintenance twice a week.

标题
UniCel DxC Clinical Analyzer Recall (FDA)

视频介绍
FDA Patient Safety News - May, 2010 - Show #98
Beckman Coulter is alerting clinical laboratories about the importance of following maintenance procedures for UniCel DxC clinical chemistry analyzers.

Speaker #1: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration

Speaker #2: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration