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

According to the company’s announcement, the company is going out of business and will not be able to continue fulfilling post-market responsibilities for the following products.

Three of the products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio™ Ketone Test Strips, and HealthyWiser KetoFast™ Ketone Test Strips) have been violatively distributed without appropriate premarket clearance or approval, which potentially could result in inaccurate test results due to a lack of performance evaluation by the FDA.

The recalled products were the One Step® Pregnancy Test, One Step® Ovulation Test, hCG Pregnancy Cassette, Am I Pregnant Pregnancy Midstream Test, restiBio™ Ovulation and Pregnancy Strips, and more.

According to the FDA, consumers with unused tests manufactured by Universal Meditech Inc. should stop using the device immediately and discard any remaining stock in the trash.

The FDA has mandated that these products bear a Unique Device Identifier (UDI) on their labeling, but Universal Meditech has failed to comply with this requirement.

The FDA also noted that this product is exempted from 510(k), so it was legally distributed without being reviewed or cleared by the FDA. However, the “FDA Cleared” verbiage on the product labeling was misleading and violative.

Universal Meditech Inc. has distributed the products to distributors in California, New York, New Jersey, and Florida, and these products may have been further sold to end consumers nationwide across the United States.

Consumers with questions may contact the legal attorney of the company via telephone at +1(702)871-9888 between the hours of 9 AM and 5 PM, P.S.T. Consumers may also contact the legal attorney of the company via e-mail at [email protected].