Dexcom has announced a recall of two lots of its G7 continuous glucose monitoring sensors after they were stolen during the destruction process and subsequently sold by unauthorized third parties. The company discovered through ongoing quality and accounting reviews that sensors designated as scrap were diverted before destruction.
The affected lots are 1725204004 and 1725069002. Dexcom traced sales of this unauthorized product to Pharmsource, LLC, an unapproved distributor supplying some independent pharmacies and DME distributors in the United States. Pharmacies that purchased from Pharmsource are advised to review their inventory carefully.
Users with sensors from lot 1725204004 face an increased risk of skin infection due to improper sterilization, while lot 1725069002 sensors have an elevated risk of providing no readings. Dexcom urges customers not to use these affected sensors and to contact US Customer Support at 1-844-478-1600 for replacements. More information is available at www.dexcom.com/theft-check.
Jake Leach, president and CEO of Dexcom, said, "Nothing matters more to Dexcom than the safety of our users and maintaining the trust of the diabetes community." He added that the company is working closely with regulators and other authorities to ensure user safety, investigate the theft, and hold perpetrators accountable.
Dexcom is notifying customers directly, with initial communications focused on the US market. There have been no reported severe adverse events associated with the stolen product. The company continues to collaborate with the FDA and other authorities on the investigation.