Class I — Lifescan Inc
| Recalling firm | LifeScan U.S. LLC |
|---|---|
| Registered facility | LifeScan U.S. LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE. |
| Product | All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch® Verio IQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch® Verio IQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by peop… |
| Quantity | US 710,413 |
| Distribution | USA Nationwide Distribution |
| Initiated | 2013-03-11 |
| Classified | 2013-04-12 |
| Terminated | 2015-08-03 |
| Recall number | Z-1074-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Lifescan Inc (Z-1074-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64624/
Alerts for LifeScan U.S. LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.