Letter From Roche Diagnostics Corporation
This is the text of a letter from Roche Diagnostics Corporation.
Contact the company for a copy of any referenced enclosures.
Dear Healthcare Professional:
Roche Diagnostics Corporation is aware that some lots of Advantage
II test strips which are intended solely for distribution outside
of the U.S. have been repackaged as Accu-Chek® Comfort Curve®
test strips and reimported into the U.S., in some cases with altered
expiration dates
These lots were never distributed in the U.S. and are not cleared
for sale in the U.S. by the FDA.
The issues that we have identified with use of these products
include:
- Expiration dates extended beyond the Roche assigned expiration
date, which may affect the accuracy of results.
- These test strips were manufactured for non-U.S. markets and
are calibrated differently from U.S. test strips (e.g., plasma
versus whole blood)
- Product performance could have been adversely affected by improper
storage or handling conditions by the persons who altered the
expiration dates
The affected product, along with the correct expiration dates,
is listed in the table below.
| Product lot number |
Expiration date |
| 445662 |
2/28/03 |
| 445620 |
2/28/03 |
| 445718 |
4/30/03 |
| 445705 |
7/31/03 |
If you have any of these lot numbers you should discontinue use
immediately. You should either return this product to the place
of purchase or contact us at 1-800-858-8072 for further instructions.
As we continue to work with FDA to resolve this issue, we ask that
you provide us with any information that you might have with respect
to where you purchased any of these lots.
We would also appreciate it if you would alert us, at the above
phone number, to any unusual appearance in packaging or lot/expiration
dating on any Roche diagnostic blood glucose test strips.
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