All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System… — Class I medical device recall Z-1074-2013
Terminated recall by Lifescan Inc, reported 2013-04-24, distributed nationwide. The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying
| Recall number | Z-1074-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lifescan Inc, Milpitas, CA, United States |
| Recall initiated | 2013-03-11 |
| Classified | 2013-04-12 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2015-08-03 |
| Distributed | Nationwide (US) |
| Quantity | 710,413 |
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¿ VerioIQ 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¿ VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
Reason for recall
The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1074-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.