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Urgent Medical Device Recall: OneTouch® UltraSmart® Meters with serial numbers beginning with TC, TD, TF or TG

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November 17, 2006

Please pay special attention to this product notification if you use a OneTouch® UltraSmart® Blood Glucose Meter and the serial number on the back of your meter begins with any of the specific two-letter combinations: TC, TD, TF or TG.

 Back of OneTouch UltraSmart Meter
Example: Back of OneTouch UltraSmart Meter

If you do not have a OneTouch UltraSmart Meter, or you do but your serial number does not begin with one of the specified two-letter combinations, this issue does not apply to you and you may disregard this notice.

If this issue does apply to you, then this notice is to inform you that, due to a potential issue with leaking batteries in certain OneTouch UltraSmart Blood Glucose Meters, LifeScan is replacing the batteries in the OneTouch UltraSmart Meters affected by this issue and, when necessary, the meters themselves.

Leaking Batteries in Certain OneTouch UltraSmart Meters

Every OneTouch UltraSmart Meter comes with two AAA batteries already installed in the back of the meter. LifeScan has recently become aware that certain OneTouch UltraSmart Meters shipped in 2005 (serial numbers beginning with TC, TD, TF or TG) may contain batteries with a higher-than-normal chance for leakage.

This leakage in the meter's battery compartment could cause residue and/or corrosion, which could—in turn—damage the battery contacts and/or cause the batteries to die sooner than normal. As a result, your meter may not turn on or will show a battery warning earlier than would normally be expected.


Example: OneTouch UltraSmart Battery Warnings

The U.S. Food and Drug Administration has been notified of this action.
Please be aware that this issue does not affect any other LifeScan Products.

What You Should Do


For Consumers
Please call LifeScan Customer Service, 866 621-4851, if you have a OneTouch UltraSmart Blood Glucose Meter and the serial number on the back of your meter begins with: TC, TD, TF or TG.

When you call, the Customer Service representative will help you determine if your meter's batteries or the meter itself need replacement. If they do, LifeScan will send you the necessary replacement batteries or meter at no charge.

Continue to Test Your Blood Sugar


If you call LifeScan and we arrange to send you new batteries or a new OneTouch UltraSmart Meter, please ensure that you continue to properly manage your diabetes while waiting for your replacement. While you wait for replacement batteries, you may continue to test with your OneTouch UltraSmart Meter if it still turns on and allows you to perform a test. (You can rely on the OneTouch UltraSmart Meter to provide accurate results.)

For Health Care Professionals and Pharmacists/Distributors
1. Health Care Professionals: If you are using any OneTouch UltraSmart Meters in your practice to test blood sugar, please check the serial numbers on the back of these meters. Please call LifeScan Customer Service if any of the serial numbers begin with: TC, TD, TF or TG.

2. Pharmacists/Distributors: Please compare the lot numbers of any OneTouch UltraSmart Meters in your inventory and sequester any inventory of OneTouch UltraSmart Meters you have that are subject to recall—only the specified lot numbers. If you do not have product from the specified lot numbers, your meters are not subject to this recall. Return the recalled OneTouch UltraSmart Meters per your normal return procedure.

3. We also ask that you share this information with any of your patients/customers who use a OneTouch UltraSmart Meters.

How to Contact LifeScan


We apologize for any confusion or inconvenience this issue may cause you.
If you have any additional questions, please contact us directly:

  • Consumers: 866 621-4851
  • Health Care Professionals: 866 621-4852
  • Pharmacists: 866 621-4854
  • Distributors: Contact Global Account Services at 800 600-7226, option 1

For Health Care Professionals/Pharmacists/Distributors
OneTouch® UltraSmart® Meter Lot Numbers Subject to Recall

Finished Good Lot

Finished Good Lot

Finished Good Lot

Finished Good Lot

Finished Good Lot

V0502001X

V0502058X

V0502104X

V0503047X

V0503107X

V0502002X

V0502059X

V0502105X

V0503049X

V0503108X

V0502003X

V0502060X

V0502106X

V0503050X

V0503109X

V0502004X

V0502061X

V0502107X

V0503051X

V0503110X

V0502005X

V0502062X

V0502108X

V0503052X

V0503116X

V0502006X

V0502063X

V0502109X

V0503053X

V0503117X

V0502007X

V0502064X

V0502110X

V0503054X

V0503118X

V0502008X

V0502065X

V0502111X

V0503055X

V0503119X

V0502009X

V0502066X

V0502112X

V0503056X

V0503120X

V0502010X

V0502067X

V0502113X

V0503057X

V0503121X

V0502011X

V0502068X

V0502114X

V0503069X

V0503122X

V0502012X

V0502069X

V0503010X

V0503070X

V0503123X

V0502023X

V0502070X

V0503011X

V0503071X

V0503124X

V0502026X

V0502071X

V0503012X

V0503072X

V0503125X

V0502027X

V0502072X

V0503013X

V0503073X

V0503126X

V0502028X

V0502073X

V0503014X

V0503074X

V0503127X

V0502029X

V0502074X

V0503015X

V0503075X

V0503128X

V0502030X

V0502075X

V0503016X

V0503076X

V0503129X

V0502031X

V0502076X

V0503017X

V0503077X

V0503130X

V0502032X

V0502077X

V0503018X

V0503078X

V0503131X

V0502033X

V0502078X

V0503019X

V0503079X

V0503132X

V0502034X

V0502079X

V0503020X

V0503080X

V0503133X

V0502035X

V0502080X

V0503021X

V0503081X

V0503134X

V0502036X

V0502081X

V0503022X

V0503082X

 

V0502037X

V0502082X

V0503023X

V0503083X

 

V0502038X

V0502083X

V0503024X

V0503084X

 

V0502039X

V0502085X

V0503025X

V0503088X

 

V0502040X

V0502086X

V0503026X

V0503089X

 

V0502041X

V0502087X

V0503027X

V0503090X

 

V0502042X

V0502088X

V0503028X

V0503091X

 

V0502043X

V0502089X

V0503029X

V0503092X

 

V0502044X

V0502090X

V0503030X

V0503093X

 

V0502045X

V0502091X

V0503031X

V0503094X

 

V0502046X

V0502092X

V0503032X

V0503095X

 

V0502047X

V0502093X

V0503033X

V0503096X

 

V0502048X

V0502094X

V0503034X

V0503097X

 

V0502049X

V0502095X

V0503035X

V0503098X

 

V0502050X

V0502096X

V0503036X

V0503099X

 

V0502051X

V0502097X

V0503037X

V0503100X

 

V0502052X

V0502098X

V0503038X

V0503101X

 

V0502053X

V0502099X

V0503039X

V0503102X

 

V0502054X

V0502100X

V0503040X

V0503103X

 

V0502055X

V0502101X

V0503041X

V0503104X

 

V0502056X

V0502102X

V0503043X

V0503105X

 

V0502057X

V0502103X

V0503045X

V0503106X

 

 

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