OMTMO One Step Ovulation (LH) Test Strips REF 200-07
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of co
What to do
FDA enforcement status: Ongoing
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCSamson International Recalls Bellevue and Oaklynn Canopy Bed Frames Due to Impact and Injury Hazards2026-04-02
- FDAHealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips2023-05-22
- FDAHealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP2023-05-22
- FDAOne Step Ovulation Test REF 200-012023-05-22
- FDALem Fertility LH Ovulation Test (Strip) REF 200-072023-05-22
- FDAOne Step Pregnancy Test REF 100-012023-05-22
- FDADiagnosUS Ovulation Predictor Midstream REF 200-172023-05-22
- FDADeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-132023-05-22
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →