Z-0630-03

OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)

Name: Z-0630-03 OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)
Creator: Lifescan Inc
Published: 2003-01-13
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2003-01-13 / Terminated / root cause: manufacturing process

FDA source

Lifescan Inc began a recall of OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use) on 2003-01-13. The reason FDA records is "The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap". 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-0630-03
Status: Terminated
Initiated: 2003-01-13
Posted: 2003-03-12
Terminated: 2003-08-21
Recalling firm: Lifescan, Inc.
Product: OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Firm contacted all accounts by letters of 1/13/03 requesting replacement of the recall product.
Quantity in commerce: 3,679,000 units
Distribution: Distribution of the product is worldwide and nationwide. Distribution in the United States was between April/02 to June/02. U.S. Government/Military or Canadian distribution is unknown at this time.
Product codes and lots: Test Strips with Off-Center Confirmation Dot Part Number Lot Number Exp. Date Description 010-797-02, 191303A005, 10/03, SureStepPro Strips (50), 010-797-02, 192113A005, 10/03, SureStepPro Strips (50), 010-797-02, 194382A004, 11/03, SureStepPro Strips (50), 020-052-01, E-187250A, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-03, E-187250B, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-01, F-189831A, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-01, F-192063A, 10/03, 100-Count OneTouch SureStep Test Strips, 010-359-04, G-190477A, 10/03, 50-Count OneTouch SureStep Test Strips, 020-052-01, E-182852A, 5/03, 100-Count OneTouch SureStep Test Strips, Defective Test Strip Bottle Cap Part Number Lot Number Exp. Date Description 010-797-02, 205206A004, 02/04, 50-Count SureStepPro Test Strips, 010-797-02, 205913A012, 03/04, 50-Count SureStepPro Test Strips, 010-797-02, 205946A004, 03/04, 50-Count SureStepPro Test Strips, 020-052-02, F-204252B, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204296A, 1/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204620A, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204668B, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-205519A, 3/04, 100-Count OneTouch SureStep Test Strips, 010-359-04, H-204583A, 12/03, 50-Count OneTouch SureStep Test Strips, 010-359-04, H-205890B, 3/04, 50-Count OneTouch SureStep Test, Strips ------------- F-204098B, 2/04, 50-Count OneTouch SureStep Medicare Test Strips

Product code CGA

K970556Class IISurestep Pro Blood Glucose Monitoring SystemLifescan, Inc. / cleared 1997-05-12

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)