Beckman Coulter Inc. – FDA Warning Letter

On June 21, 2010, the FDA issued a Warning Letter to Beckman Coulter, Inc. for marketing the AccuTnI on the Access Immunoassay System in the U.S. without marketing clearance or approval. The FDA determined this device is intended for diagnosis and has undergone significant modifications affecting performance, requiring premarket approval or clearance.

The device is cited as adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application under section 515(a) or an investigational device exemption (IDE) under section 520(g). It is also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device into commercial distribution, as required by section 510(k).

Beckman Coulter was instructed to take prompt action to correct these deviations and respond in writing within fifteen working days, detailing corrective steps and preventative measures. Failure to comply could result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts. The letter specifically addresses premarket review and does not cover other regulatory obligations.