The Food and Drug Administration (FDA) is warning patients and caregivers not to use test strips from previous owners or ones not authorized for sale in the US.
Test strips are used as part of at-home testing for various health reasons; these include blood glucose monitoring for diabetes and International Normalized Ratio (INR) monitoring for warfarin therapy management, among others. The Agency noted that pre-owned and unauthorized test strips are being sold by individuals on sites such as Amazon, Craigslist, and eBay.
Using pre-owned test strips can lead to inaccurate results as the strips may not have been stored properly or may have expiration dates that have been changed. In addition, pre-owned test strip vials may contain small amounts of blood from a previous owner, increasing the possibility for infection.
Test strips that are not authorized for sale in the US may be of poor quality and may not have been reviewed by the FDA to assure safety and effectiveness. Inaccurate results from the use of these test strips may lead to dosage adjustments that could potentially cause serious injury or death.
The FDA is advising healthcare providers to talk to their patients about the risks associated with using pre-owned and unauthorized test strips. Providers should also discuss safe and affordable options with patients and caregivers, such as patient assistance programs.
“In alerting the public and helping them to recognize the illegal sale of these products, we hope to prevent unnecessary harm to people who rely on testing,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Centers for Devices and Radiological Health.
For more information visit FDA.gov.