Precision Xtra 70745Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00093815707455), received between Dec 1, 2021 and Dec 1, 2021 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K060768); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING A HIGH READING FROM THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED A HIGH READING OF 14.4 MMOL/L WHICH WAS HIGHER THAN A LAB READING OF 3.6 MMOL/L. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "D" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 12911080 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060768. One submission often covers many models, so check the product and lot details in each record.

• Z-1558-2020 · Nov 14, 2019 · Terminated
  FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810