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# Universal Meditech Recalls All Test Products
- URL: https://www.fdaweb.com/universal-meditech-recalls-all-test-products/
- Published: 2023-09-01T12:00:00.000Z
- Updated: 2026-09-14T18:54:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155237

FDA says Universal Meditech has recalled all test products manufactured between 3/2021 and 11/2022 because the company is ceasing operations and is not able to continue fulfilling any post-market responsibilities for distributed products. Additionally, [it says](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-issues-nationwide-recall-all-products-manufactured-between-march-2021-and?utm%5Fmedium=email&utm%5Fsource=govdelivery) three products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio Ketone Test Strips and HealthyWiser KetoFast Ketone Test Strips) has been “violatively distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.” Those having unused tests are advised to discard them.