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FreeStyle Lite 70819Recalls & reported problems

Abbott Diabetes Care Inc · FreeStyle Lite Blood Glucose Test Strips · Class 2

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 00699073708199), received between Nov 14, 2017 and Nov 14, 2017 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K092602); 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

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionNov 14, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF "HI" (GREATER THAN 500 MG/DL), 90 MG/DL AND 91 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" 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: No Known Impact Or Consequence To Patient

    MAUDE report 7030184 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092602. One submission often covers many models, so check the product and lot details in each record.

  • Z-0485-2014 · Nov 18, 2013 · Terminated
    FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6
  • Z-0486-2014 · Nov 18, 2013 · Terminated
    FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.