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keto mojo β-ketone & blood glucose monitoring system TD-4279Recalls & reported problems

Keto-Check, Inc. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858538007103), received between Dec 13, 2018 and Dec 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 13, 2018Incorrect, Inadequate or Imprecise Result or Readings

    I HAVE BEEN USING THE KETONE METER FROM KETO MOJO (HTTPS://KETO-MOJO.COM/COLLECTIONS/ALL/PRODUCTS/TD-4279-KETONE-AND-GLUCOSE-METER) WITH TEST STRIPS PURCHASED DIRECTLY FROM KETO MOJO. RECENT PATCHES OF TEST STRIPS HAVE BEEN GIVEN CONFLICTING READINGS THAT FALL WELL OUTSIDE OF THE EXPECTED VARIANCE / ERROR RANGE OF THE DEVICE AND THE TEST STRIPS.

    Patient problems: No Information

    MAUDE report 8164443 ↗

Other System, Test, Blood Glucose, Over The Counter devices

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Sources and updates

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