Universal Meditech Inc. recall records

28 reported ongoing

28 records in this archive. Latest source date May 22, 2023.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Lem Fertility LH Ovulation Test (Strip) REF 200-07

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is...

Class IIReported ongoing

Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan

Official source for Lem Fertility LH Ovulation Test (Strip) REF 200-07
FDA device enforcement

DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is...

Class IIReported ongoing

Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan

Official source for DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
FDA device enforcement

DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is...

Class IIReported ongoing

Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan

Official source for DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
FDA device enforcement

DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is...

Class IIReported ongoing

Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan

Official source for DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
FDA device enforcement

DiagnosUS Ovulation Predictor Midstream REF 200-17

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is...

Class IIReported ongoing

Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan

Official source for DiagnosUS Ovulation Predictor Midstream REF 200-17
FDA device enforcement

OMTMO One Step Ovulation (LH) Test Strips REF 200-07

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is...

Class IIReported ongoing

Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan

Official source for OMTMO One Step Ovulation (LH) Test Strips REF 200-07
FDA device enforcement

Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box wit...

Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

Class IReported ongoing

Distribution: U.S. Nationwide distribution in the states of CA, and TX.

Official source for Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) ...

Reasons in these listed records

  • Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their t...
  • Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

These examples come from this result page and are not a ranking of every recall reason.

Checking Universal Meditech Inc.

Is there a recall on universal meditech inc. right now?

This archive contains 28 records, including 28 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

Keep checking