FDA warns against tests from secret Chinese-owned lab in Reedley. Here are product names

Thaddeus Miller
·2 min read
A photo taken during the spring 2023 investigation of a Chinese-owned laboratory operating illegally in Reedley, CA, shows the contents of one freezer found stored in the warehouse, including containers and vials of blood, serum, and biological agents.

Federal regulators are warning residents not to use pregnancy, ovulation or any other tests manufactured by the lab recently found operating illegally in Fresno County.

The U.S. Food and Drug Administration said in a news release that tests manufactured by Universal Meditech Inc., whose Reedley lab was discovered in recent weeks, may not be safe or effective.

The company, whose owners live in China, informed federal authorities the lab is no longer operating or supporting its tests, the FDA said.

The slew of different tests, the FDA said, have been sold online by four distributors: AC&C Distribution LLC., HealthyWiser, Home Health US Inc. and Prestige Biotech Inc.

The company was found to be operating in Reedley in December after being forced out of the city of Fresno late last year, officials have said.

The tests in question may not be labeled as UMI products by the manufacturer and could have been distributed by other manufacturers, the FDA said.

UMI has started a recall for tests that have gone out to distributors, but has not initiated a recall for tests that have already reached consumers, the FDA said.

Federal officials said their concerns about the tests led to the warning.

Officials said consumers should not buy any of the tests listed, and should destroy and toss out any they may already have.

Anyone who has used one should not trust the results, the FDA said. Officials recommend re-testing with a different product and — if still insure — consumers should seek advice from a medical professional.

Consumers should also report any problems experienced with the use of the tests to the FDA’s MedWatch Adverse Event Reporting program.

Here are the tests federal officials warned against:

  • 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

For any further questions, email the Division of Industry and Consumer Education at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.