RegWardenFDA facility compliance records
Facility

LifeScan U.S. LLC

2 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2013: 2 recalls2’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Devices registered here (2)

  • Glucose Oxidase, Glucose
    Product code CGA (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345
  • System, Test, Blood Glucose, Over The Counter
    Product code NBW (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345

Recalls & enforcement

  • Class ITerminated2013-03-11
    The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.
  • Class IITerminated2013-02-25
    When OneTouch® Ultra and OneTouch® Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “LifeScan U.S. LLC (FEI 3042301847) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3042301847-lifescan-u-s-llc/

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