Z-1129-2013Class II

LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of...

Name: Z-1129-2013 LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of...
Creator: Lifescan Inc
Published: 2013-02-25
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2013-02-25 / Terminated / root cause: manufacturing process

FDA source

Lifescan Inc began a recall of LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels on 2013-02-25. FDA classified it as Class II and gives the reason as "When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though...". 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-1129-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-25
Posted: 2013-04-17
Terminated: 2013-10-23
Recalling firm: Lifescan, Inc.
Product: LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: LifeScan sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers may contact OneTouch Healthcare Professional Line at 866-461-0089 for questions about this notice.
Quantity in commerce: 132,301 units total
Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 10, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NO, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SO, TN, TX, UT, VA, VI, VT, WA, WI,WV, and WY, and the countries of Russia and Ukraine.
Product codes and lots: 2AA2G01, Exp. Date: 7-31-2014; 2AA2G02, Exp. Date: 7-31-2014; 2AA2G03, Exp. Date: 8-31-2014; 3AA2G04, Exp. Date: 12-31-2014; 3AA2G05, Exp. Date: 12-31-2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1129-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1129-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-17
Z-1130-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-17

Product code JJX

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)