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Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test
TECO DIAGNOSTICS · Model P597-25 · UDI-DI 10673486014020
JHI
Prescription
1
510(k) clearances
3,857
Adverse events (1 deaths)
47
Recalls
110
Facilities
Description
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test is a colloidal gold antibody complex based immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine. This test is for professional use in obtaining a visual qualitative result for the early detection of pregnancy.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-20 | Alere San Diego, Inc. | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. |
| 2026-08-20 | Alere San Diego, Inc. | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. |
| 2026-08-20 | Alere San Diego, Inc. | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. |
| 2026-08-20 | Alere San Diego, Inc. | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. |
| 2024-08-23 | Princeton Biomeditech Corp | This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in fal |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.