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TRUEplus
TRIVIDIA HEALTH, INC. · Model TRUEplus Ketone Test Strips · UDI-DI 00021292008178
10
510(k) clearances
187
Adverse events (1 deaths)
14
Recalls
102
Facilities
Description
TRUEplus Ketone Test Strips
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-02 | DFI Co., Ltd. | The devices were distributed without required FDA premarket clearance or approval. |
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause fa |
| 2023-10-02 | Stanbio Laboratory, LP | Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the sta |
| 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 |
| 2022-03-08 | MEDLINE INDUSTRIES, LP - Northfield | Product was improperly store which may cause a delay in results. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
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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.