Z-1074-2013Class I

All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits...

Name: Z-1074-2013 All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits...
Creator: Lifescan Inc
Published: 2013-03-11
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2013-03-11 / Terminated / root cause: software

FDA source

Lifescan Inc began a recall of 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... on 2013-03-11. FDA classified it as Class I and gives the reason as "The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1074-2013
Classification: Class I
Status: Terminated
Initiated: 2013-03-11
Posted: 2013-04-12
Terminated: 2015-08-03
Recalling firm: Lifescan, Inc.
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.
Product code: NBW System, Test, Blood Glucose, Over The Counter
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.
Root cause tag: software
FDA root cause: Software design
Action: Lifescan sent an Urgent Medical Device Voluntary Recall letter dated March 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to identify and hold all affected product in inventory and discontinue distributing. The letter states that a Lifescan sales representative will contact customers to arrange for pick up and replacement.
Quantity in commerce: US 710,413
Distribution: USA Nationwide Distribution
Product codes and lots: Part numbers: Verio IQ Systems Kits: 022 267-01, 022 267-01, 022 267-03; Verio IQ Starter Kits: 022 268 01, 022 268-02; Verio IQ Warranty Kits: 022 275 01, 022 275 02. All lots and serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1074-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1074-2013	Class I	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-12

Product code NBW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)