Z-2639-2010

One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc...

Name: Z-2639-2010 One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc...
Creator: Lifescan Inc
Published: 2010-01-07
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2010-01-07 / Terminated

FDA source

Lifescan Inc began a recall of One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA on 2010-01-07. The reason FDA records is "One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2639-2010
Status: Terminated
Initiated: 2010-01-07
Posted: 2010-10-01
Terminated: 2011-03-14
Recalling firm: Lifescan, Inc.
Product: One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips.
FDA root cause: Mixed-up of materials/components
Action: Notification was issued by the firm during the first week of February. This letter asked consignees to share the information with patients, and are asking users to contact the firm and to examine their stock for the recalled product.
Quantity in commerce: 9631 cartons, 4 vials per carton
Distribution: Product was distributed to one wholesale dealer and one distributor and 2 medical facilities in CA, OH and PA, as well as the UK.
Product codes and lots: Part Number 020-245-32, lot number 2964512, manufactured between 09/10/2009 and 09/24/2009, distributed between 09/30/2009 and 10/27/2009.

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)