Z-2027-2010

OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in...

Name: Z-2027-2010 OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in...
Creator: Lifescan Inc
Published: 2010-02-24
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2010-02-24 / Terminated

FDA source

Lifescan Inc began a recall of OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by... on 2010-02-24. The reason FDA records is "Products may provide inaccurate results at readings over 400 mg/dL". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2027-2010
Status: Terminated
Initiated: 2010-02-24
Posted: 2010-07-17
Terminated: 2010-12-08
Recalling firm: Lifescan, Inc.
Product: OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in home settings (SureStep).
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Products may provide inaccurate results at readings over 400 mg/dL
FDA root cause: Other
Action: The firm, Lifescan, Inc., issued two "Urgent Medical Device Recall" letters dated February 24, 2010 to all customers for the OneTouch SureStep Test Strips and the SureStep Pro Test Strips. The letters describes the product, problem and action to be taken by the customers. The customers were instructed to look at your test strip vials for the recalled lots and check the strips or if you have test strips from the lot, call LifeScan Customer Service at 800-574-6139 between 5 a.m. to 7 p.m. Pacific Time, seven days a week or visit www.SureStep.com. Replacement product will be shipped to you immediately at no charge. The customers were instructed to continue to test your blood glucose, while wafting for replacement. Also, the customers are asked to continue use of the meter with precautions if results over 400 units are observed. For more information, please visit www.SureStep.com or call our Healthcare Professional Line at 888-455-5627.
Quantity in commerce: 1,014,350
Distribution: Worldwide distribution: USA and countries of Europe, Latin America and Asia.
Product codes and lots: Part Number 02005201 (100 count), lot numbers 2969798, 2969251, 2982369, 2983467; Part number 01035904 (50 count), lot numbers 2969795 and 2982566; Part number 02096401 (50 count mail order pack), lot numbers 2969481 and 2998193

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)