Z-1042-2007

OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch...

Name: Z-1042-2007 OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch...
Creator: Lifescan Inc
Published: 2007-03-22
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2007-03-22 / Terminated / root cause: packaging

FDA source

Lifescan Inc began a recall of OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d)... on 2007-03-22. The reason FDA records is "Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1042-2007
Status: Terminated
Initiated: 2007-03-22
Posted: 2007-07-13
Terminated: 2008-08-15
Recalling firm: Lifescan, Inc.
Product: OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01)
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.
Root cause tag: packaging
FDA root cause: Other
Action: March 2007 via letters to consumers and consignees and web postings. The firm has also set up verbal communication plans for customers who contact Lifescan by phone.
Quantity in commerce: ~33 million vials (25 strips per vial in the US, ~19 million worldwide.
Distribution: Worldwide; USA, Europe, Middle East, Africa, Latin America and Canada.
Product codes and lots: Part numbers 020-245-07 (100 pack), 020-244-07 (50 pack), 020-963-01 (50 pack mail order). Expiration dates 08/2007 through 11/2008.

Product code NBW

K062195Class IIModification to One Touch Ultra Blood Glucose Monitoring SystemLifescan, Inc. / cleared 2006-08-16

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)