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FDA: Don’t Use Pregnancy Tests Made by Failed Fresno Lab

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The Food & Drug Administration ordered a recall on Friday, Aug. 11, 2023, for test strips produced by Universal Meditech Inc. (GV Wire Composite/Paul Marshall)
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The company linked to an illegal Reedley bio lab received a second recall for one of its products — this time for its lines of test strips.

On Friday, the Food & Drug Administration issued a recall on the following tests produced by Fresno-based Universal Meditech Inc.:

  • One Step Pregnancy Test
  • DiagnosUS One Step Ovulation Test
  • HealthyWiser UriTest 10 Parameter Reagent Test Strips for Urinalysis
  • HealthyWiser UriTest UTI Test Strips
  • HealthyWiser KetoFast Ketone Test Strips
  • HealthyWiser pH-Aware pH Test Strips
  • To Life hCG Pregnancy Urine Test
  • Am I Pregnant Pregnancy Midstream Test
  • DeTec hCG Pregnancy Urine Test
  • PrestiBio Pregnancy Strips
  • PrestiBio Rapid Detection Pregnancy Test Midstream
  • PrestiBio Ovulation Strips
  • PrestiBio Urinalysis Test Strip 10 Parameters
  • PrestiBio Ketone Test Strips
  • PrestiBio Breast Milk Alcohol Test Strips

Distributors of the tests include AC&C Distribution, LLC, HealthyWiser, Home Health US Inc., and Prestige Biotech Inc. Prestige Biotech would ultimately claim UMI’s assets after the company left their south-central Fresno manufacturing facility in December 2022.

UMI is no longer providing support for the following tests, according to the news release from the FDA. The city of Fresno denied the company’s application to reopen near the Fresno Yosemite International Airport earlier in August.

The FDA also questions the safety of the tests as they can’t confirm how well the products work.

UMI recalled their own products from distributors but did not recall tests already sent out to consumers, the release stated. Recalled tests may not identify UMI as the manufacturer.

The FDA also issued a recall for UMI’s COVID tests in February, saying the tests were not verified by the agency.

Disposable plastic cups cap off an unknown liquid stored at Universal Meditech Inc. in south central Fresno. (©Nicholas Crawford, Crawford Architecture & Planning)

UMI’s Downfall

Disputes between the landlord and UMI about changes made to the building pushed the medical manufacturer out of its south-central Fresno building in December 2022.

Further financial difficulties, including a multi-million legal settlement, sent creditors after UMI. One of those creditors, Prestige Biotech Inc., named on the recall as a distributor of UMI’s tests, came into possession of the company’s assets.

Biological materials, 1,000 lab mice, and at least 20 diseases from UMI were found illegally stored at a bio lab operated by Prestige Biotech in Reedley.

City of Fresno officials denied an application from UMI to reopen earlier this month.

Health officials finished destroying biological materials from the Reedley lab on Aug. 9, according to Reedley City Manager Nicole Zieba.

Edward Smith began reporting for GV Wire in May 2023. His reporting career began at Fresno City College, graduating with an associate degree in journalism. After leaving school he spent the next six years with The Business Journal, doing research for the publication as well as covering the restaurant industry. Soon after, he took on real estate and agriculture beats, winning multiple awards at the local, state and national level. You can contact Edward at 559-440-8372 or at Edward.Smith@gvwire.com.