HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP
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
- FDADeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-132023-05-22
- FDAOne Step Pregnancy Test REF 100-012023-05-22
- FDALem Fertility LH Ovulation Test (Strip) REF 200-072023-05-22
- FDADiagnosUS Ovulation Predictor Midstream REF 200-172023-05-22
- FDAHealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips2023-05-22
- FDAOne Step Ovulation Test REF 200-012023-05-22
- FDATo Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-102023-05-22
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