Z-1596-05

LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan...

Name: Z-1596-05 LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan...
Creator: Lifescan Inc
Published: 2003-11-21
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2003-11-21 / Terminated

FDA source

Lifescan Inc began a recall of LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037 on 2003-11-21. The reason FDA records is "LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1596-05
Status: Terminated
Initiated: 2003-11-21
Posted: 2005-09-29
Terminated: 2005-11-29
Recalling firm: Lifescan, Inc.
Product: LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L.
FDA root cause: Other
Action: 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 in commerce: Approximately 572,000 units
Distribution: 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: Includes all System Kits shipped during June 2003 until December 2003

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)