Z-0823-05

LifeScan Brand InDuo Blood Glucose Meter

Name: Z-0823-05 LifeScan Brand InDuo Blood Glucose Meter
Creator: Lifescan Inc
Published: 2005-04-11
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2005-04-11 / Terminated

FDA source

Lifescan Inc began a recall of LifeScan Brand InDuo Blood Glucose Meter on 2005-04-11. The reason FDA records is "User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0823-05
Status: Terminated
Initiated: 2005-04-11
Posted: 2005-05-17
Terminated: 2007-01-24
Recalling firm: Lifescan, Inc.
Product: LifeScan Brand InDuo Blood Glucose Meter
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
FDA root cause: Other
Action: On 4/11/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions on the correction. Owner's booklet: Firm contacted all accounts by letters of 11/21/03, 2/4/2004, 2/17/04 and 2/9-10/2004 providing important information regarding the owner's booklet.
Distribution: Distribution of the product is worldwide. ***Distribution in the United States was between January 15, 2001 for OneTouch Ultra Blood Glucose Meter; April 13, 1998 for OneTouch FastTake Blood Glucose Meter and November 30, 2001 for InDuo Blood Glucose Meter.*** The total number of quantities shipped to consignees is approx. 1.8 Million. Of these, Approx. 282,000 were shipped to Pharmacies and Healthcare Professionals (including Diabetes Educators, Primary Care Physicians, Endocrinologists), Approx. 800 were shipped to Mail Order companies that distribute OneTouch ¿ FastTake¿ and OneTouch ¿ Ultra¿ products, and Approx. 130,000 were shipped to E-mail End User Notifications to LifeScan database of OneTouch¿ Ultra¿, OneTouch¿ FastTake¿ and InDuo¿ product users. Ultra, InDuo, FastTake Meters Global Distribution include: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Caribbean, CEE, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latin America, Latin America, Lebanon, Malaysia, Malta, MEA, Mexico, Netherlands, Norway, Oman, Pasean, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia/Gulf Countries, Singapore, Slovakia, Slovenia, South Africa, Spain, Sub-Saharan Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam, and Yemen. Owner's booklet: The recall product was distributed in the U.S. only. LifeScan manufactured and distributed OneTouch Ultra System Kits with the affected OneTouch Ultra Meter Owner's Booklets between March 31, 2003 and October 3, 2003.
Product codes and lots: ALL CODES: All lot numbers and serial numbers

Product code NBW

K024194Class IIOne Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. / cleared 2003-02-07

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)