• Roche in a lawsuit accused manufacturers and sellers based in India of selling counterfeit versions of its Accu-Chek devices on Amazon.
• Roche said the test strips are expired or nearly expired products that are repackaged with counterfeit labels bearing Roche's registered U.S. trademarks and fake expiration dates.
• Amazon is not a defendant in the case but is alleged to have held the counterfeit products at U.S. facilities and shipped them to customers.

Roche, one of the world's largest biotech companies, said "dangerous counterfeits" of its diabetes medical devices ended up for sale on Amazon to be bought by patients throughout the United States.

Roche accused manufacturers and sellers based in India of selling counterfeit versions of its Accu-Chek devices, which are used to test blood glucose levels. The company made the claim in a federal lawsuit unsealed late Friday.

"Patients know that Roche's Accu-Chek medical devices are safe, sterile and accurate," the complaint said. Roche said the counterfeit test strips are expired or nearly expired products that are repackaged with counterfeit labels bearing Roche's registered U.S. trademarks and fake expiration dates.

It warned that the counterfeit devices are "likely to give false or inaccurate measurements of blood glucose levels, putting patients at risk of severe and life-threatening complications, such as hyperglycemia and over- or under-dosages of insulin."

The lawsuit, which was filed under seal in May in the U.S. District Court in the Brooklyn borough of New York City, named as defendants four companies and their executives, all based in India. Roche is seeking unspecified damages.

After the suit was filed, a judge granted Roche's request for a temporary restraining order to stop the defendants from selling the counterfeit products. The Amazon stores that were offering the products for sale appear to have been taken down.

Amazon is not a defendant in the case, but Roche claims that as part of the alleged scheme all of the counterfeit products sent to the U.S. were stored at Amazon warehouses across the country, including in Brooklyn. The products are typically shipped to businesses and individuals within 48 hours of landing at Amazon facilities.

"Amazon currently has untold numbers of these dangerous counterfeit medical devices in its warehouses across the country, ready to deliver to unsuspecting American consumers at the click of a button," the complaint said.

Roche said the counterfeiters participated in Amazon's Fulfillment by Amazon program, through which "Amazon agrees to receive, store, and accept orders on behalf of the counterfeiters; to pick, pack, and ship the counterfeit goods; and to provide customer service for the counterfeiters. ... Amazon, in return, receives a sizable percentage of the revenue from the counterfeit sales," according to the complaint.

An Amazon spokesman told CNBC that the company has "a zero tolerance policy for counterfeit products. We have proactive measures in place to prevent counterfeit products from being listed and continuously monitor our store. If we identify an issue, we act quickly to protect customers and brands, including removing counterfeit listings and blocking accounts, and collaborating with brands and law enforcement to protect our customers from bad actors attempting to abuse our store."

The complaint was filed on behalf of Roche Diabetes Care Inc., Roche Diabetes Care GmbH and Hoffmann-La Roche Inc, by attorneys with the New York-based law firm Patterson Belknap Webb & Tyler.

The defendants are JMD Enterprises doing business as DKY Store USA, JMD Enterprises founder and owner Dileep Kumar Yadav, JMD International, JMD International owner and founder Abhishek Jain, Medical Hub_USA Store, Medical Hub_USA owner Ratnakar Sharma, Authentic Indian Store and Authentic Indian Store owner Atikur Rahman.

CNBC contacted the defendants for comment, but has not yet received responses.

A spokesperson for Roche told CNBC that the company does not comment on ongoing lawsuits.

Counterfeit medical devices

Roche's Accu-Chek diabetes care medical devices, used by millions of patients, include Accu-Chek glucometers, blood glucose test strips and lancets. The company's blood glucose test strips and lancets can be purchased with or without a prescription at pharmacies and online marketplaces, including Amazon.

The lancets are specialized disposable needles used to draw blood for testing.

The packaging on the counterfeit devices at the center of the lawsuit includes a misspelling of the name of the product as well as fake serial numbers and expiration dates, according to the complaint.

The company launched an investigation into the counterfeits in late March when a whistleblower reached out with information, according to the complaint. Its investigators then purchased the products from the three Amazon stores listed in the complaint, the lawsuit said.

As recently as May, a customer left a negative review on Amazon's platform, complaining that he had ordered test strips from the DKY Store but received a different product. In March, a different customer said the lancets she purchased from DKY were fake.

Roche did not specify how long the counterfeit items were being sold on Amazon, or how many ultimately made it to customers.

The issue of potentially dangerous glucose test strips emerged in 2019 when the Food and Drug Administration warned against using test strips from a previous owner or ones not authorized for sale in the U.S. At the time, the FDA said faulty test strips were being sold via online marketplaces and individual sellers.

In 2011, Johnson & Johnson said it found counterfeit versions of its glucose test strips in India.

CNBC in March reported findings of an investigation into stolen items sold on Amazon's marketplace via organized retail crime rings. The report centered on millions of dollars of items stolen from Ulta Beauty that were being sold for more than a decade on the platform.

And in 2023, a CNBC investigation revealed how counterfeiters illegally alter prescription medications, which are then funneled into a gray market supply chain for resale to pharmacies and ultimately to patients.