Z-0453-2007

LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package...

Name: Z-0453-2007 LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package...
Creator: Lifescan Inc
Published: 2006-09-29
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2006-09-29 / Terminated

FDA source

Lifescan Inc began a recall of LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc... on 2006-09-29. The reason FDA records is "Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0453-2007
Status: Terminated
Initiated: 2006-09-29
Posted: 2007-01-05
Terminated: 2007-11-27
Recalling firm: Lifescan, Inc.
Product: LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
FDA root cause: Other
Action: The firm has issued notification on 9/29/06 to consumers and hospital end users known to the firm and direct accounts that received the recalled product. The firm also posted the notice on the website, and customer service scripting was developed to notify callers.
Quantity in commerce: 26,398 units (both recall numbers Z-0452/3-2007
Distribution: Nationwide to Al, AZ, CA, CN, DE, FL, GA, IL, IN, KT, KY, LA, MA, MD, MI, MN, MS, MO, NE, NJ, NM, and TX.
Product codes and lots: Lot number 2634187008, Part number 010-797-02

Product code CGA

K023194Class IISuresteppro/surestepflexx Professional Blood Glucose Management SystemLifescan, Inc. / cleared 2002-10-24

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)