(Reuters) – Blood-testing company Theranos Inc was sued on Thursday, accused of endangering customer health through “massive failures” that misrepresented the accuracy and quality of its blood tests, according to court papers.
The proposed class action was brought in the U.S. District Court for the Northern District of California by the law firm Hagens Berman Sobol Shapiro LLP.
The complaint accuses the company of breach of contract, false advertising and consumer fraud, among other claims. It estimated that thousands of consumers could be eligible to join the lawsuit, citing Theranos’ claims that it had performed more than 6 million tests.
Officals at Theranos did not immediately respond to requests for comment.
Theranos last week notified U.S. federal health regulators that it voided results from its Edison blood-testing devices for two years, the Wall Street Journal reported, citing a person familiar with the matter.
The company informed the Centers for Medicare and Medicaid Services that it has issued tens of thousands of corrected blood-test reports to doctors and patients, nullifying some results and revising others, the Journal reported.
Theranos once touted its Edison device as a ground-breaking technology able to test blood from just a pinprick.
The complaint focuses on materials published by both Theranos and Walgreens Boots Alliance, which had agreed to offer blood testing from Theranos’ Edison device at dozens of wellness centers in Walgreen’s stores in Arizona and California.
CMS said in January that the blood-testing company’s practices violated several clinical-laboratory regulations, jeopardizing patient health and safety.
Theranos, which recently expanded its board to include Dr. Fabrizio Bonanni, a former Amgen Inc and Baxter International Inc executive, has been under investigation by several U.S. regulators in the recent past.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.