Beckman Coulter (BEC) Announces Faulty Testing with UniCel DxI
On February 5, 2010, Beckman Coulter (NYSE: BEC) issued a notice advising customers who use a UniCel DxI platform to perform AccuTnI testing that values obtained with the DxI have been demonstrated to have a positive bias compared to values obtained when using an Access or Access 2 platform to perform AccuTnI testing. We have identified some approaches to resolve the issue and are working closely with the FDA to select the most appropriate solution and to determine next steps and timing. We currently believe this action will not have a material adverse affect on our results of operations; however, we can not provide any assurances at this time that the action will not have material adverse effects on our business.
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