FDA Medical Device Recalls (openFDA)
Lifescan Inc: LifeScan Brand InDuo Blood Glucose Meter
- Recall number
- Z-0823-05
- Recalling firm
- Lifescan Inc
- Product
- LifeScan Brand InDuo Blood Glucose Meter
- Status
- Terminated
- Initiated
- 2005-04-11
- Posted
- 2005-05-17
- Terminated
- 2007-01-24
- Reason
- 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.
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- ALL CODES: All lot numbers and serial numbers
- 510(k) numbers
- ["K024194"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 2939301
- Firm city
- Milpitas
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28