• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA issues Class I recall for Roche Diagnostics’ warfarin test strips

November 2, 2018 By Sarah Faulkner

FDA-logo-newThe FDA today issued a Class I recall for certain lots of Roche Diagnostics‘ warfarin test strips used with the CoaguCheck test meter devices.

Roche voluntarily recalled the strips in September, warning that for patients and doctors who use at-home devices to monitor levels of the blood thinner, the devices may yield inaccurate results. The FDA said today that the devices should not be used to adjust drug dosages.

The recall involves more than 1.1 million packages of the CoaguChek XS PT test strips that were distributed across the U.S. between Jan. 12 and Oct. 29.

A Class I recall is the most serious type of recall and indicates that the use of the affected devices could cause serious injuries or death.

Roughly 90 medical device reports and two serious patient injuries involving strokes have been reported to the FDA involving the CoaguChek XS PT test strips.

Roche Diagnostics told the FDA that the cause of the problem is a recent re-calibration of the test strips to a different international standard. The company plans to give new batches of re-calibrated test strips to its customers by the end of this month.

“These strips are widely used and we are working diligently to warn healthcare providers and the public about the dangers associated with this recall. Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in prepared remarks.

“We are also working with the company on the swift removal of the recalled strips and to ensure the new corrected strips are distributed to patients and health care providers as quickly as possible,” Shuren added.

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

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: rochediagnostics

IN CASE YOU MISSED IT

  • Senseonics closes public offering, private placement with Abbott
  • Embecta eyes shift from insulin delivery to broader medical supplies focus
  • Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
  • Sequel Med Tech to pair automated insulin delivery system with Abbott’s future dual glucose-ketone sensor
  • Medtronic to separate Diabetes business unit

Reader Interactions

Comments

  1. Mary says

    November 4, 2018 at 6:15 am

    No one contacted me as to what will be done to replace strips. Are we supposed to go to the Dr to get blood drawn to check INR and should that be done immediately because strips may have given wrong reading already.

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS