Z-0435-06

LifeScan OneTouch Ultra Test strips, lot number 2528640

Name: Z-0435-06 LifeScan OneTouch Ultra Test strips, lot number 2528640
Creator: Lifescan Inc
Published: 2005-11-01
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2005-11-01 / Terminated

FDA source

Lifescan Inc began a recall of LifeScan OneTouch Ultra Test strips, lot number 2528640 on 2005-11-01. The reason FDA records is "Product may be defective and may give low inaccurate glucose results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0435-06
Status: Terminated
Initiated: 2005-11-01
Posted: 2006-01-24
Terminated: 2006-07-26
Recalling firm: Lifescan, Inc.
Product: LifeScan OneTouch Ultra Test strips, lot number 2528640
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Product may be defective and may give low inaccurate glucose results.
FDA root cause: Other
Action: Recall was initiated in early November. Notifications were sent on November 21, 2005. The firm has also posted recall notices on its website, and Customer Service Scripting will be available to address questions from callers.
Quantity in commerce: 7321 boxes of 100 count test strips (29338 vials)
Distribution: 7 direct consignees (2 wholesale dealers and 5 distributors_ located in CA, PA, IL, WI, MN, SD, OK, CN, MA, MI.
Product codes and lots: Lot number 2528640, par tnumber 020-245-07, Expiration date April 2006

Product code CGA

K043197Class IIOnetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. / cleared 2005-05-20

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)