Universal Meditech Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 28 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0063-2024 | Class II | DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 | May 22, 2023 |
| Z-0045-2024 | Class II | HealthyWiser UriTest" UTI Test Strips REF 900-UTI | May 22, 2023 |
| Z-0068-2024 | Class II | OMTMO One Step Ovulation (LH) Test Strips REF 200-07 | May 22, 2023 |
| Z-0054-2024 | Class II | PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips | May 22, 2023 |
| Z-0055-2024 | Class II | PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS | May 22, 2023 |
| Z-0062-2024 | Class II | Lem Fertility LH Ovulation Test (Strip) REF 200-07 | May 22, 2023 |
| Z-0046-2024 | Class II | HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips | May 22, 2023 |
| Z-0053-2024 | Class II | PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Stri | May 22, 2023 |
| Z-0058-2024 | Class II | DiagnosUS One Step LH Ovulation Test Strip REF 200-07 | May 22, 2023 |
| Z-0056-2024 | Class II | PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE | May 22, 2023 |
| Z-0066-2024 | Class II | DiagnosUS Pregnancy Test Midstream REF 100-17 | May 22, 2023 |
| Z-0061-2024 | Class II | Lem Fertility hCG Pregnancy Urine Test REF 100-12 | May 22, 2023 |
| Z-0064-2024 | Class II | DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 | May 22, 2023 |
| Z-0047-2024 | Class II | HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP | May 22, 2023 |
| Z-0048-2024 | Class II | DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 | May 22, 2023 |
| Z-0067-2024 | Class II | DiagnosUS Ovulation Predictor Midstream REF 200-17 | May 22, 2023 |
| Z-0059-2024 | Class II | DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 | May 22, 2023 |
| Z-0065-2024 | Class II | DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 | May 22, 2023 |
| Z-0042-2024 | Class II | One Step Pregnancy Test REF 100-01 | May 22, 2023 |
| Z-0044-2024 | Class II | HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 | May 22, 2023 |