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Medical Devices / Submissions and Approvals

FDA Issues Warning for Pre-Owned and Unauthorized Test Strips

April 11, 2019
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The FDA said patients who use test strips to monitor for certain diseases or health conditions—such as tests for blood glucose or the blood thinner warfarin—should be wary of marketers that sell pre-owned or unauthorized test strips, the FDA said.

The illicit test strips may be sold on online markets like eBay, Craigslist, and Amazon, or directly from an online seller, the agency said.

Pre-owned test strips may have been tampered with, stored in shoddy conditions or could have altered or removed expiration dates, all of which may lead to inaccurate results. Unauthorized strips could be of poor quality and may not give an accurate result, the FDA said.

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