Beckman Coulter has been slapped with a class-action lawsuit over how it modified its troponin assay kits and the financial damage that resulted from the move.
The suit, filed Sept. 3 in the US District Court for the Central District of California on behalf of certain Beckman shareholders, alleges that Beckman and certain of its officers violated Securities and Exchange Commission rules by failing to disclose that it modified its troponin test kits without "proper FDA approval."
In addition, the tests, which went on to be recalled, caused an "adverse financial impact" on the company.
Plaintiffs in the suit would be Beckman shareholders who held stock in the company between July 31, 2009, and July 22, 2010.
As I wrote July 7, the FDA in a June 21 letter slammed Beckman for allegedly violating agency rules by selling an "adulterated," "misbranded," and "unapproved" version of its AccuTnI troponin kits performed on its Access immunoassay system.
The case traces its roots to February when Beckman informed customers of a positive bias in results for its troponin kits that run on the UniCel DxI system. The company recommended that customers using the troponin kits discontinue using them if an alternative methodology was available, and noted it was working with the FDA to resolve the issues.
However, in an SEC filing the previous day, Beckman said the FDA believes the modifications, which included running the test on the DxI and Access systems, were made without proper clearances.
In June, I wrote that Beckman said the FDA had allowed it to continue selling the troponin kits that are run on its Access instruments for as long as it takes Beckman to receive an updated 510(k) clearance for the tests.
Writing in an SEC filing that day, Beckman said "we will not be able to provide troponin test kits to US customers that are not currently performing troponin testing on Access instruments" until it obtains clearance.
A Beckman spokesperson did not immediately respond to a request for comment.