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September 28, 2005
URGENT: PRODUCT RECALL
OneTouch™ Horizon® Test Strips
LifeScan India voluntary product removal and replacement
Dear Valued Customer:
If you use, recommend, distribute or sell OneTouch™ Horizon® Test Strips, we want to make you aware that LifeScan is voluntarily removing and offering replacement for the following lots of OneTouch Horizon Blood Glucose Test Strips:
| Part No. |
| Affected Lot Numbers |
| Description |
| 2101401 | | 2537696
2539997
2560265 | | 25 Count OneTouch
Horizon Test Strips |
Note: Only the lots of OneTouch Horizon Test Strips listed are covered by this notice. No other OneTouch™ products are included in this replacement program. |
The test strips from the specified lot numbers may result in incomplete filling of the confirmation window on the test strip before count down begins, which could result in no reading being displayed on the meter screen. In addition, some strips may not completely fill and, while these give a result that is usually accurate, a very small number of these may result in a reading that is lower than the true value.
Please compare the lot numbers of any OneTouch Horizon Test Strips in your possession with the lot numbers listed above. The lot number appears on the outside of the test strip box and on the label of the test strip bottle. If you do not have product from the lot numbers listed above, your test strips are not subject to this recall and can be used. Kindly ignore this notification.
How To Return the Affected Test Strips and Receive Replacement OneTouch Horizon Test Strips
If you have any OneTouch Horizon Test Strips from the lot numbers listed above, call LifeScan Customer Service at 1600-22-55-44 or write to Customer Service and tell the customer service representative how many bottles of test strips you have that need to be returned and replaced. LifeScan will give you direction on how to return the test strips and will send you replacement bottles of test strips at no charge to you.
LifeScan India Customer Service Mailing Address
Johnson & Johnson Medical India
Johnson House,
64-66, Senapati Bapat Marg,
Mahim, Mumbai - 400 016
While you wait for your replacement bottles of test strips to arrive, you may continue to test with current lot strips and in order to ensure proper system performance, you must remember two important points when you test:
- Proper Blood Application to the Test Strip: When the flashing appears on the display, immediately hold the blood drop to the sample channel at the end of the test strip. Do not push your finger against the test strip. If the window is not full before the countdown begins, do not add more blood. Discard the test strip and retest with a new test strip. If you have trouble filling the test strip, contact your LifeScan Customer Service Representative for assistance.
- If You Get Unexpected Results: Low or high blood glucose readings can indicate a potentially serious medical condition. If your blood glucose reading is unusually low, less than 70 mg/dL, treat this condition according to the recommendations of your healthcare professional immediately (although the low reading may be due to the problem mentioned above, it is safest to treat the low glucose reading). If your blood glucose reading is unusually high, higher than 240 mg/dL, repeat the test with a new test strip. If the result is high again, treat this condition according to the recommendations of your healthcare professional.
Your Complete Satisfaction is Our Top Priority
At LifeScan, our vision is to create a world without limits for people with diabetes. We know that you rely on our products and services to help you manage your diabetes. We take this responsibility seriously. If at any time you determine or suspect that there is a problem with your OneTouch Horizon Meter or Test Strips, please call LifeScan Customer Service at 1800-22-55-44 for immediate assistance.
We apologize for any confusion or inconvenience this issue may cause. Thank you for your continued support of LifeScan.
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