Amazon is accused of selling counterfeit diabetes medical devices, according to Roche.

• Manufacturers and sellers based in India were accused in a lawsuit by Roche of selling counterfeit versions of its Accu-Chek devices on Amazon.
• Roche stated that the test strips being sold are expired or almost expired products that have been repackaged with fake labels bearing Roche's registered U.S. trademarks and fraudulent expiration dates.
• Allegedly, Amazon held counterfeit products at U.S. facilities and shipped them to customers, although the company is not a defendant in the case.

Its diabetes medical devices were sold on Amazon despite being counterfeit, according to one of the world's largest biotech companies.

Roche accused Indian manufacturers and sellers of selling counterfeit versions of its Accu-Chek devices, which are used to test blood glucose levels, in a federal lawsuit unsealed late Friday.

Roche's Accu-Chek medical devices are known to be safe, sterile, and accurate, according to patients. However, the company has stated that the counterfeit test strips it sells are expired or nearly expired products that are repackaged with fake labels bearing Roche's registered U.S. trademarks and fake expiration dates.

The fake devices may provide incorrect blood glucose measurements, endangering patients with severe and potentially fatal complications, including hyperglycemia and insulin over- or under-dosages.

In May, a lawsuit was filed in the U.S. District Court in Brooklyn, New York City, with four Indian companies and their executives named as defendants. Roche is seeking damages.

The judge granted Roche a temporary restraining order to halt the sale of counterfeit products by the defendants, and it seems that the Amazon stores selling these products have been removed.

Roche alleges that all of the counterfeit products sent to the U.S. were stored at Amazon warehouses, including in Brooklyn, and were typically shipped to businesses and individuals within 48 hours of landing at Amazon facilities. However, Amazon is not a defendant in the case.

The complaint stated that Amazon has numerous counterfeit medical devices in its warehouses nationwide, which are ready to be shipped to unsuspecting American consumers with just a button click.

According to the complaint, Amazon agreed to receive, store, and accept orders on behalf of counterfeiters through its Fulfillment by Amazon program. In return, Amazon received a significant portion of the revenue from the sales of counterfeit goods.

Amazon has a strict zero tolerance policy for counterfeit products. The company has proactive measures in place to prevent counterfeit products from being listed and continuously monitors its store. If any issues are identified, Amazon acts quickly to protect customers and brands, including removing counterfeit listings and blocking accounts, and collaborating with brands and law enforcement to safeguard its customers from fraudulent actors.

The law firm Patterson Belknap Webb & Tyler filed a complaint on behalf of Roche Diabetes Care Inc., Roche Diabetes Care GmbH, and Hoffmann-La Roche Inc.

The defendants in this case 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.

Roche's representative stated to CNBC that the company does not provide commentary on ongoing legal actions.

Counterfeit medical devices

Roche's Accu-Chek diabetes care medical devices, utilized by millions of patients, consist of Accu-Chek glucometers, blood glucose test strips, and lancets. These blood glucose test strips and lancets can be obtained 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 lawsuit alleges that the packaging of the counterfeit devices contains incorrect product name, fake serial numbers, and expiration dates.

According to the lawsuit, the company's investigators bought the counterfeit products from three Amazon stores in late March after a whistleblower provided information.

In March, a customer claimed that the lancets she bought from DKY were fake, while in May, another customer complained that he received a different product from the DKY Store despite ordering test strips.

Roche did not disclose the duration or quantity of counterfeit products sold on Amazon that reached customers.

In 2019, the Food and Drug Administration issued a warning against using unauthorized glucose test strips, which were being sold online and by individual sellers.

In 2011, reported that it discovered counterfeit versions of its glucose test strips in India.

In March, CNBC reported on an investigation into organized retail crime rings selling stolen items on Amazon's marketplace, with millions of dollars worth of items being sold for over a decade.

In 2023, a CNBC investigation exposed how prescription medications are illegally altered by counterfeiters and sold through a gray market supply chain to pharmacies and patients.