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Urgent Medical Device Recall: OneTouch® SureStep® and SureStep® Pro Test Strips

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A Letter To Customers

September 29, 2006

LifeScan is voluntarily recalling:

The U.S. Food and Drug Administration has been informed of this action.

These lots contain some test strips whose confirmation dot either remains white or does not turn completely blue even though an adequate sample has been applied. A white or incompletely blue confirmation dot on the back of the test strip, as noted in the SureStep Pro Test Strip package insert/Operator's Guide, and OneTouch SureStep Test Strip package insert/Owner's Booklet, may lead to: (1) error messages, such as Remove strip, Er2 or Error 2(b), (2) symbols, such as Remove Test Strip symbol, or (3) inaccurately low results. Users should always follow proper procedures as provided by the labeling (and for professionals-their institution).

Product Subject to Recall:

Product Name

Part Number

Lot Number

SureStep® Pro Test Strips

010-797

2634187008

OneTouch® SureStep® Test Strips

020-052

2627353


Affected Test Strips

Lot # 2634187008 only

Lot # 2627353 only

SureStep Pro Test Strips
OneTouch SureStep Test Strips
   

Unaffected Test Strips
Please be aware that this recall does not affect any other products from LifeScan

OneTouch Ultra Test Strips
OneTouch Test Strips

What You Should Do

For Consumers
If you have any OneTouch SureStep Test Strips from Lot # 2627353, please call LifeScan Customer Service: 888 811 7226.

LifeScan will send an equivalent amount of replacement test strips to you at no charge. While you wait for your replacement test strips to arrive, you may continue to test with your current strips provided that they are performing correctly. In order to ensure proper system performance, you must remember when you test:

  1. Make sure you have applied enough blood to the test strip by checking that the confirmation dot turned completely blue.
  2. If white patches or streaks appear on the confirmation dot, you may not have applied enough blood to obtain an accurate test or the test strip may be defective. You must start over with a new test strip.
  3. Refer to the testing instructions in either the test strip package insert or the meter's Owner's Booklet for further guidance on testing.

Your replacement OneTouch SureStep Test Strips will arrive with a pre-paid U.S. mail business reply label (to use for returning the recalled test strips specified).

For Health Care Professionals and Pharmacists

  1. Locate and confiscate any inventory of OneTouch SureStep Test Strips you have that are subject to recall—only lot 2627353.
  2. We also ask that you share this information with any of your patients who use a OneTouch SureStep Meter.
  3. Return the recalled product per your normal product return procedure.

For Hospital and Multi-patient Facilities:

  1. Locate and sequester any inventory of SureStep®Pro Test Strips you have that are subject to recall—only lot number 2634187008—and OneTouch® SureStep® Test Strips—only lot number 2627353.
  2. Return the recalled product per your normal product return procedure.

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: 888 811 7226
  • Health Care Professionals: 888 341-2292
  • Pharmacists: 877 903-0872
  • Hospital/Multi-patient Facilities: 866 693-0598

Thank you for your continued support of LifeScan.

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