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Universal Meditech Inc. Expands Nationwide Recall to All Products Manufactured between March 2021 and November 2022

Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that: i. The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of these distributed ....

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Pregnancy, ovulation tests included in recall due to potentially inaccurate test results

Universal Meditech Inc. initiated a nationwide recall of 16 products it manufactured between March 2021 and November 2022. ....

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Universal Meditech Inc. Issues Nationwide Recall of All Products Manufactured Between March 2021 and November 2022

On July 1, 2023, Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that: i.The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of ....

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FDA Issues Update on Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration

The U.S. Food and Drug Administration (FDA) is providing an update to the February 27, 2023 Letter to Health Care Providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta Valve and Trifecta Valve with Glide Technology (GT) ....

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FDA Maintains Focus On "Intended Use" For Software-Enabled Medical Devices

On June 21, 2023, the U.S. Food and Drug Administration issued a warning letter to Zyto Technologies, Inc. , citing Zyto s promotion of its Hand Cradle Galvanic Skin Response device and associated. ....

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