Walgreens hasn’t told Theranos it’s pulling back on partnership, CEO claims

If Walgreens really is taking a break from opening more Theranos centers, no one at the drugstore chain has told Elizabeth Holmes about it. Is Walgreens scrutinizing their relationship with Theranos? “Well, they haven’t said that to us,” Holmes said.

Her remarks came at a Fortune conference today. Walgreens said it won’t open any more Theranos centers until it had further examined its relationship with the troubled Silicon Valley blood testing company, according to a report in The Wall Street Journal. Holmes said she hasn’t been told the same.

Walgreens and Theranos seem to have some trouble communicating; the same Journal article says that Walgreens hadn’t heard Theranos was no longer using its finger-prick tests until it read an investigation into Theranos in the newspaper.

That’s not the only communication breakdown Theranos is experiencing. The FDA told Theranos the agency considered the Nanotainer an unapproved medical device in documents from a lab inspection. In those documents, the FDA inspector told the company that the Nanotainer was a “Class II device being used without FDA clearance.” (Class II devices require special labels, and manufacturers must demonstrate certain standards are met.) “You are currently shipping this uncleared medical device in interstate commerce, between California, Arizona, and Pennsylvania,” the report said. Today, Holmes told Fortune’s audience, “I voluntarily chose to stop using the Nanotainer tube.” It is currently being used for the single test that Theranos has FDA clearance for: herpes.

Correction: The FDA has indicated the Nanotainer device is not approved; an earlier version of this post inaccurately characterized the FDA’s response to the Nanotainer in the documents.