Z-1070-2009

OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood...

Name: Z-1070-2009 OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood...
Creator: Lifescan Inc
Published: 2008-11-25
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2008-11-25 / Terminated / root cause: manufacturing process

FDA source

Lifescan Inc began a recall of OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc... on 2008-11-25. The reason FDA records is "Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1070-2009
Status: Terminated
Initiated: 2008-11-25
Posted: 2009-03-17
Terminated: 2010-12-06
Recalling firm: Lifescan, Inc.
Product: OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Urgent: Medical Device Recall letters, dated 11/24/2008 were issued to all consignees on November 25, 2008, requesting return of affected lots to LifeScan and instructing how to obtain replacement strips free of charge. A request for sub-recall communications were made as well, and the firm posted notification on its website. Customer service and Sales account reps were provided information to address questions regarding the recall.
Quantity in commerce: 23,288 vials
Distribution: Worldwide Distribution -- USA and the Caribbean.
Product codes and lots: Lot codes 2802961 and 2802962

Product code NBW

K022724Class IISurestep Blood Glucose Monitoring SystemLifescan, Inc. / cleared 2002-09-12

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)