FreeStyle Precision H 71181Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00093815711810), received between May 22, 2019 and May 22, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “No Device Output” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K070984); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryMay 22, 2019No Device Output; No Device Output

  A CALLER FROM A HEMODIALYSIS CLINIC REPORTED THEIR CLINIC ADC METER DID NOT WORK WHEN THEY ATTEMPTED TO PERFORM A CUSTOMER'S A BLOOD GLUCOSE CHECK BY INSERTING THE TEST STRIP INTO THE METER. ON (B)(6) 2019, THE CUSTOMER EXHIBITED UNSPECIFIED SYMPTOMS OF HYPOGLYCEMIA AND WAS TREATED BY AN HCP WITH "SUGAR GEL" AND RUSHED TO THE HOSPITAL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 8634096 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070984. 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
• Z-0994-2011 · Dec 22, 2010 · Terminated
  Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips
• Z-0998-2011 · Dec 22, 2010 · Terminated
  Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;