Z-0004-2009

One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count...

Name: Z-0004-2009 One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count...
Creator: Lifescan Inc
Published: 2008-09-19
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2008-09-19 / Terminated / root cause: manufacturing process

FDA source

Lifescan Inc began a recall of One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of... on 2008-09-19. The reason FDA records is "Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low 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-0004-2009
Status: Terminated
Initiated: 2008-09-19
Posted: 2008-11-21
Terminated: 2010-12-27
Recalling firm: Lifescan, Inc.
Product: One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent: Medical Device Recall letters, dated 09/19/2008, were sent to consumer end users, direct account distributors and wholesalers, health care providers, and pharmacists notifying them of the recall. The letter states that if customers have strips from Lot 2829235, they should call LifeScan at 1-866-247-1281 and tell customer service that they have strips that need to be replaced. Customer service and QA scripts were provided to LifeScan staff to provide to any callers who inquire about the recall. The distributors and wholesalers were to locate and sequester any inventory from the affected Lot 2829235; request all recalled inventory from customers; call Carolina Logistics for an RGA; and when only the affected returned product is received, a credit will be issued.
Quantity in commerce: 35308 vials
Distribution: Nationwide Distribution --- including Puerto Rico.
Product codes and lots: Lot number 2829235

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)