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Universal Meditech Inc. FDA Recalls
28 recalls on file across devices, 1 of them Class I and 28 still open. Matched by name to UVV.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| DiagnosUS Pregnancy Test Midstream REF 100-17Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| Lem Fertility hCG Pregnancy Urine Test REF 100-12Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| OMTMO One Step Ovulation (LH) Test Strips REF 200-07Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| One Step Pregnancy Test REF 100-01Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| PrestiBio Ovulation Strips REF 200-4 60 LH Test StripsClass IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test StripsClass IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test stripsClass IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| One Step Ovulation Test REF 200-01Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTSClass IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| Lem Fertility LH Ovulation Test (Strip) REF 200-07Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| PrestiBio Pregnancy Strips REF 100-4 25 HCG Test StripsClass IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTSClass IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREEClass IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| DiagnosUS One Step LH Ovulation Test Strip REF 200-07Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| HealthyWiser UriTest" UTI Test Strips REF 900-UTIClass IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| Am I Pregnant? One Step HCG Pregnancy Test REF 100-17Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIPClass IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| DiagnosUS Ovulation Predictor Midstream REF 200-17Class IIMay 22, 2023Universal Meditech Inc. was violatively distributing PrestiB |
| Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Class INov 28, 2022Distribution of SARS-CoV-2 Antigen Rapid Test Kits without F |