Beckman Coulter Warning Cites Unapproved Assay Changes

Beckman Coulter received a warning letter citing it for making unapproved changes to a cardiac diagnostic. The letter addresses the use of the AccuTnI with Beckman’s Access immunoassay system. The company initiated a Class I recall in March of the AccuTn1 used with its Unicel DxI immunoassay system because of the unapproved changes. That recall will be completed this month when the assay will have been removed from all of the DxI systems used in the U.S., Mary Luthy, Beckman Coulter spokeswoman, said.
The GMP Letter