By Kirell Lakhman
The FDA slammed Beckman Coulter for allegedly violating agency rules by selling an "adulterated," "misbranded," and "unapproved" version of its AccuTnI troponin test kits performed on its Access immunoassay system.
According to Beckman's website, the Access AccuTnI assay "is designed for rapid turnaround and improved sensitivity and specificity, helping laboratories meet a new standard of care in the management of patients with cardiac disease."
The agency announced its findings in a letter dated June 21 addressed to Beckman CEO Scott Garrett.
The letter, sent by OIVD Chief Alberto Gutierrez, said Beckman is in violation of section 201(h) of the Federal Food, Drug, and Cosmetic Act because the AccuTnI on the Access system "is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body."
An FDA review of documentation provided by Beckman "reveals that you have made significant modifications that may affect the performance of your product and have not obtained marketing approval or clearance before offering your modified product for sale, which is a violation of the law," Gutierrez said in the letter.
The agency said the product is "adulterated … because you do not have an approved application for premarket approval … or an approved application for an investigational device exemption," he added
The device is also "misbranded … because you did not notify the agency of your intent to introduce the device into commercial distribution," Gutierrez said.
The agency warned that "failure to promptly correct these deviations may result in regulatory action" by the FDA "without further notice."
The FDA's announcement comes two months after Beckman said it would remove the AccuTnI troponin test kits from use with the company's UniCel DxI immunoassay system on May 31 after notifying customers that a positive bias could lead to elevated AccuTnI results when run on system.
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