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Blood Ketone Monitoring System
e-Linkcare Meditech Co., Ltd · Model PM900B · UDI-DI 06971404130911
10
510(k) clearances
187
Adverse events (1 deaths)
14
Recalls
102
Facilities
Description
Blood ketone Monitoring Meter with Blood Ketone Test Strips are intended for use for the quantitative measurement of B -hydroxybutyrate (B -ketone) in fresh capillary whole blood or venous whole blood.
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.