FreeStyle 12050Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle 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 00699073120502), received between Nov 10, 2020 and Nov 10, 2020 — 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 (K092638); 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
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
CUSTOMER'S SON REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 49 MG/DL AND 249 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: Insufficient Information
MAUDE report 10819774 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K092638. One submission often covers many models, so check the product and lot details in each record.
- Z-1211-2014 · Feb 19, 2014 · TerminatedFreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system opera
- Z-1212-2014 · Feb 19, 2014 · TerminatedFreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test St
Other Glucose dehydrogenase, glucose devices
- OneTouch Verio IQ 022-275LifeScan Europe GmbH · Glucose dehydrogenase, glucose6,035 reports
- OneTouch Verio 022-659LifeScan Europe GmbH · Glucose dehydrogenase, glucose4,219 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 50 Test StripsTrividia Health, Inc. · Glucose Dehydrogenase, Glucose2 deaths2,548 reports
- FreeStyle Lite 70805Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose2,366 reports
- FreeStyle Freedom Lite 70920Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose1,037 reports
- FreeStyle Freedom Lite 70914Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose760 reports
- Accu-Chek Guide 08256292001Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose476 reports
- ACCU-CHEK AVIVA PLUS 06908268001Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose472 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.