FDA doubles down on warfarin test strip recall

The FDA this week alerted patients and doctors about test strips used to monitor levels of the blood thinner warfarin, expanding and reiterating its warning that the products shouldn’t be used to adjust a person’s drug dosage.

The agency’s latest notice is related to the Class I recall of Roche‘s CoaguChek meters and test strips, which the FDA issued in November last year. The initial recall involved more than 1.1 million packages of CoaguChek XS PT test strips that were distributed across the U.S. from Jan. 12 – Oct. 29 of 2018.

This week, the agency focused in on strips distributed by Terrific Care/Medex Supply. The FDA noted that these strips weren’t included in the initial recall because they weren’t authorized for sale in the U.S. Terrific Care/Medex Supply bought the Roche test strips from “an unknown source,” according to the U.S. regulatory body, and imported them into the U.S. for sale.

“Monitoring warfarin dosing is a critical part of using the drug properly to prevent and treat blood clots. Using faulty strips can lead to errors in medication dosage that could cause serious harm or death in some patients. That’s why it’s so concerning that this distributor continued to sell these test strips in the U.S. even though domestic sales had been stopped due to safety concerns. To reduce risks to patients, we’re warning health care providers and the public about the dangers associated with this product,” FDA chief Dr. Scott Gottlieb said in prepared remarks.

“Distributing products that are not labeled or authorized for sale in the United States raises significant concerns for us in view of the serious safety issues with these test strip devices, and our work on this matter is not finished. Our top priority is the immediate safety of patients, and we’re taking steps to ensure the products that this company distributed are removed from the market,” Gottlieb added.

The FDA noted that patients should have their blood drawn from a vein and monitored using an alternative meter device or lab test to check their warfarin levels.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston 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. REGISTER NOW